OECD SIDS ALKANES, C 18

- 30 , CHL ORO

1 

## SIDS Initial Assessment Report

For

SIAM

- 2 9

October 20

- 23 , 200 9

1. Chemical Category: Long Chain Chlorinated Paraffins (LCCPs)

2. CAS Registry Numbers and Substance Names: Substance Name/Description CAS Number

Paraffin waxes and hydrocarbon waxes, ch loro 63449

- 39

- 8

Alkanes, C 18

- 28 , chloro 85535

- 86

- 0

Paraffin oils, chloro 8 5422

- 92

- 0

3. Sponsor Country: United Kingdom (U. K .)

4. Shared Partnership with: Chlorinate d Paraffins Industry Association (C PIA )

5. Roles/Responsibilities of the Partners:

• Name of industry sponsor /consortium Chlorinated Paraffins Industry Association 1250 Connecticut Avenue, NW, Suite 700 Washington, DC 20036

• Process used Documents drafted by the Environment Agency ( UK EA) , the UK Health and Safety Executive (HSE) and CPIA.

6. Sponsorship History

• How was the chemical or category brought into the SIDS Program? Industry sponsored the assessment of LCCPs under the ICCA HPV Initiative and the U.K. under the UK Coordinated Ch emicals Risk Management Programme

.

7. Review Process Prior to the SIAM:

8. Quality Check Process: Industry:
Data searches were conducted of literature, databases, and internal company files. Critical biological studies discussed in the SIAR were reviewe d for quality by the U.K. and industry
sponsors and assigned a reliability code, based on the review process guidance of Klimisch et al . (1999). Only those studiesOECD SIDS ALKANES, C 18

- 30 , CHL ORO

2 given a reliability code of 1 or 2 were evaluated in the assessment report, though all studi es have been included in the dossier. The summary formats for select endpoints w e re based on descriptions in the OECD Form and Guidance for preparing and submitting the SIDS DOSSIER, which is in the Manual for Investigation of HPV Chemicals

. U. K . Governm ent : Environment Agency (UK) has conducted an extensive risk assessment of LCCPs that was published in 2009. This document was used in the preparation of this SIAR.

9. Date of Submission:

10. Date of Last Update:

11. Comments:OECD SIDS ALKANES, C 18

- 30 , CHL ORO

3 

## CONTENTS

1 IDENTITY

................................ ................................ ................................ ................................ .............................. 5

1.1 Identification of the Substance

................................ ................................ ................................ ....................... 5

1.2 Purity/Impurities/Additives

................................ ................................ ................................ ............................ 7

1.3 Physico

- Chemical properties

................................ ................................ ................................ .......................... 7

1.4 Category Justification

................................ ................................ ................................ ................................ ..... 12

2 GENERAL INFORMATION ON EXPOSURE

................................ ................................ ................................ ..... 12

2.1 Production Volumes and Use Pattern

................................ ................................ ................................ ............. 12

2.2 Environ mental Exposure and Fate

................................ ................................ ................................ .................. 14 2.2.1 Sources of Environmental Exposure

................................ ................................ ................................ ... 14 2.2.2 Photodegradation

................................ ................................ ................................ ................................ . 14 2.2.3 Stability in Water

................................ ................................ ................................ ................................ . 16 2.2.4 Transport between Environmental Compartments

................................ ................................ .............. 16 2.2.5 Biodegr adation

................................ ................................ ................................ ................................ .... 18 2.2.6 Bioaccumulation

................................ ................................ ................................ ................................ .. 20 2.2.7 Other Information on Environmental Fate

................................ ................................ .......................... 20

2.3 Human Exposure

................................ ................................ ................................ ................................ ............ 20 2.3.1 Occupational Exposure

................................ ................................ ................................ ........................ 20 2.3.2 Consumer Exposure

................................ ................................ ................................ ............................ 20

3 HUMAN HEALTH HAZARDS

................................ ................................ ................................ ............................. 21

3.1 Effects on Human Health

................................ ................................ ................................ ................................ 21 3.1.1 Toxicokinetics, Metabolism a nd Distribution

................................ ................................ ..................... 21 3.1.2 Acute Toxicity

................................ ................................ ................................ ................................ ..... 22 3.1.3 Irritation

................................ ................................ ................................ ................................ ............... 23 3 .1.4 Sensitisation

................................ ................................ ................................ ................................ ........ 24 3.1.5 Repeated Dose Toxicity

................................ ................................ ................................ ...................... 24 3.1.6 Mutagenicity

................................ ................................ ................................ ................................ ........ 28 3.1.7 Carcinogenicity

................................ ................................ ................................ ................................ ... 29 3.1.8 Toxicity for Reproduction

................................ ................................ ................................ ................... 31

3.2 Initial Assessment for Human Health

................................ ................................ ................................ ............. 34

4 HAZARDS TO THE ENVIR ONMENT

................................ ................................ ................................ ................. 36

4.1 Aquatic Effects

................................ ................................ ................................ ................................ ............... 36

4.2 Terrestrial Effect s

................................ ................................ ................................ ................................ ........... 46

4.3 Initial Assessment for the Environment

................................ ................................ ................................ .......... 46

5 REFERENCES

................................ ................................ ................................ ................................ ........................ 48



## Tables

Tab le 1: Physico

- chemical properties............................................................................................. 7

Table 2: Estimated atmospheric half

- lives for long

- chain chlorinated paraffins

........................................... 1 6OECD SIDS ALKANES, C 18

- 30 , CHL ORO

4 Table 3: Estimated Henry’s Law Constants

......................................................... ............................ 1 7

Table 4: Estimated K OC values for long

- chain chlorinated paraffins from structure

..................................... 1 7

Table 5: Results of level III fugacity modeling for long

- chain chlorinated paraffins

.................................... 1 8

Table 6: Biodegradation Results Reported by Hildebrecht (1972)

............ ...... ............ ............ ... ............ 1 9

Table 7: Acute Toxicity

.......................................................................................................... . . 2 2

Table 8: Skin Irritation

............................................................................................................ 2 3

Table 9: Eye Irritation

............................................................................................................. 2 3

Table 10: Repeat

- Dose Toxicity

................................................................................................. 2 6

Table 11: In Vitro Bacterial Cell Genetic Toxicity........................................................................... 2 8

Table 12: In Vitro Mammalian Cell Genetic Toxicity........................................................................ 2 9

Tabl e 13: In Vivo Genetic Toxicity.........................................................

.................................... 2 9

Ta ble 14: Developmental Toxicity.............................................................................................. 3 3

Table 15: Acute Toxicity of LCCPs to Fish.................................................................................... 3 7
Table 16: Acute Toxicity of LCCPs to Aquatic Invertebrates............................................................... 3 8

Table 17: Ch ro nic Toxicity to Fish............................................................................................. 41

Table 18: Chronic To xicity to Aquatic Invertebrates........................................................................ 43
Table 19: Summary of Key Chronic Aquatic Toxicity Data for LCCPs.................................................. 4 7OECD SIDS ALKANES, C 18

- 30 , CHLORO

5 

## SIDS Initial Assessment Report

1 I DENTITY

1.1 Identification of the Substance

CAS Registry Numbers and IUPAC Names: Substance Name CAS Number Alkanes, C 18

- 30 , chloro 63449

- 39

- 8
Alkanes, C 18

- 28 , chloro 85535

- 86

- 0 Paraffin oils, chloro 8 5422

- 92

- 0

Molecular Formula: C n H 2n+2

- y Cl y , where n = 18 to 32 and y = ~4 to ~30

Example Structural Formulas:

Molecular Weights: Typically 400 to >1000 g/mole

Synonyms: Long Chain Chlorinated Paraffins, LCCPs

Chlorinated paraffins (CP) are derived from the chlorination of straight

- chain hydrocarbon substances ( i. e. , n

- paraffins, n

- alkanes) . CPs are classified according to their carbon

- chain length and percentage of chlorination, with carbon

- chain lengths generally ranging from C 10 to C 30 an d chlorination from approximately 3 0 % to greater than 70% by weight. CPs are generally divided into three categories based on their carbon chain

- length:

• Short: C 10 to C 13

• Mid : C 14 to C 17

• Long: C 18 to C 30

Short

- Chain CPs (SCCPs) and Mid

- Chai n CPs (MCCPs) have been previously reviewed under the OECD SIDS program . The UK Environment Agency published a risk assessment on LCCPs in 2009 ( UK EA 2009)

.

Most CPs a re complex substances containing components with different carbon chain lengths and di fferent degrees of chlorination, although all have a common structure in that no secondary carbonOECD SIDS ALKANES, C 18

- 30 , CHLORO

6 atom carries more than one chlorine atom. The content of each commercial CP product is determined by the nature of the n

- alkane feedstock used and the overa ll degree of chlorination. The substances identified in this assessment have generally been identified based on the se two variables ( e.g. , C 22

- 26 , 43% chlorine by weight). 

### While LCCPs range from C 18 

### to C 30 

### , the dominant commercial products are generally g reater than 20 carbons (i.e., C 20

- 30 ) and are produced from paraffin feedstocks that typically have an average carbon chain length between 22

- 25 carbon atoms). These LCCPs have a very small percentage of chain length constituents C 20 or less ( 0. 2 % C 20 and trace or non

- detectable levels of C 1 9 ). Figure 1 provides an assessment of the carbon chain length distribution for typical 

### C 20

- 30 LCCP product s

.

0 5 10 15 20

C21 C22 C23 C24 C25 C26 C27 C28Percentage composition

Carbon chain length Figure 1: Carbon chain length distribution for C 20

- 30 products

Source: Zitko and Arsenault (1977) as cited in UK EA ( 200 9 )

There are also so me minor LCCP products predominantly in the C 18

- 20 range that are derived from different n

- alkane feedstocks (generally centering on C 18/19 alkyl chain lengths) that frequently contain a sizeable amount ( 10

- 20%) of C 17 and minor amounts (≤1%) of C 16

. As such, for several endpoints data on mid

- chain chlorinated paraffin s (MCCPs), C 14

- 17 , have been considered as read

across data in the evaluation of these C 18

- 20 products.

The actual physical form of the chlorinated paraffins can vary from free

- flowing mo bile liquids to highly viscous, glassy liquids, to waxy solids and powders (BUA, 1992; Houghton, 2003)

. Generally, the higher the chlorine content the more solid the product. The same hydrocarbon feedstocks are used to produce C20

- 30 products that are liqu id and solid ; it is the extent of chlorination that determines whether the product is a liquid (usually 4 0

- 50%) v ersus a solid (chlorine content typically 70

- 72%).

For purposes of this assessment, the LCCPs are being divided into 3 subgroups to reflect d ifferences in carbon chain length (those derived from the C 18 - C 20 hydrocarbon feedstock and those from the C 20 - C 3 0 hydrocarbon feedstock), physical state (as a result of degree of chlorination), and use pattern. These subgroups are:

- C 18 - C 20 LCCPs (Liquid)

- C 20 - C 30 LCCPs (Liquid)

- C 20 - C 30 LCCPs (Solid)OECD SIDS ALKANES, C 18

- 30 , CHLORO

7 Common LCCP Products and Their Physical States

Carbon chain Chlorine content Physical state C 18

- 20

C 20

- 30

Source: UK EA ( 200 9 )

1.2 Purity/Impurities/Additives
The purity of the chlorinated paraffin is related to the purity of the n

- p araffin used as feedstock. In North America and Western Europe, chlorinated paraffins are made from purified n

- paraffin feedstocks containing no more than 1

- 2% isoparaffins and <100 ppm (<0.01%) aro matics ( which are specifically rem oved from the paraffins feedstock by hydrodesulfurization ). The n

- alkane feedstocks may contain n

- alkanes beyond the nominal or predominant carbon number range reported for the feedstock, as such chlorinated paraffin comm ercial products may contain some constituents outside this range. The carbon number range (C 18 - C 30 ) of the LCCP category is generally fully encompassing of the main commercial products, though some C 18

- 20 products may contain a significant (10

- 20%) amount of C 17 chlorinated alkane

.
Stabilisers such as long

- chain epoxidised soya oil are added to some LCCPs to inhibit the release of hydrogen chloride at elevated temperatures. These are used at concentrations <0.05% by weight

.

1.3 Physico

- Chemical properties

T able 1 presents representative physico

- chemical data for each of the three subgroups of the LCCP category. Due to the range of carbon chain lengths and differing degrees of chlorination of the substances in the LCCPs category, a range of values for each ph ysico

- chemical property is expected and trends have been highlighted

. Where estimated data are presented, r epresentative chemical
structures have been used as inputs resulting in a single estimated value. Single representative values for key endpoints (e

. g ., octanol

- water partition coefficient, vapour pressure, water solubility) required for fate and behaviour endpoint modelling have been selected following appraisal of the measured and estimated data

.

Table 1 : P hysico

- chemical pro perties Property Substance Value Rel. Ref. Remarks

Physical State Varies from liquid to viscous liquid to semi

- solid to solid

Pour/ Melting Point C18

- 20 (liquid) All liquid LCCPs have pour points in the range of C18

- 20, 20% Cl

- 26 ° C 4 INEOS (2005).
C18

- 20, 40.5% Cl

- 15 ° C 4 INEOS (2005). LIQUIDS ca. 30

- 35% wt. Cl ca. 44% wt. Cl ca. 48

- 52% wt. Cl

ca. 40

- 43% wt. Cl ca. 48

- 54% wt. Cl

ca. 70

- 72% wt. Cl LIQUIDS

SOLIDOECD SIDS ALKANES, C 18

- 30 , CHLORO

8 Property Substance Value Rel. Ref. Remarks

(all values are pour points unless otherwise noted ) C18

- 20, 44% Cl

- 25 ° C 2 Hoechst AG (1990). approximately

- 30 o to around 10 o C

. Because of the complex nature of the substances, distinct melting points are not evident. Instead the commercial substances display pour points. While many of the data for pour points are assigned reliability 4, an overall trend is apparent making a weight of evidence approach possible. Pour points generally increase with increasing chlorine content and chain length. Solid LCCPs have softening point s C18

- 20, 47.5 Cl

- 9 ° C 4 INEOS (2005).

C18

- 20, 48% Cl

- 17 ° C 4 INEOS (2005).

C18

- 20, 52.2 Cl 2 ° C 4 INEOS (2005).

C18

- 20, 52% Cl 0 ° C 2 Hoechst AG (1990). C20

- 30 ( liquid)
C 2 0

- 30 , 41.5% Cl

- 15 ° C 4 INEOS (2005).
C 20

- 30 , 42% Cl

- 30 ° C 2 ICI (1989).
C20

- 30 , 42.15% 2 ° C 4 INEOS (2005).

C20

- 30 , 45.75% 10 ° C 4 INEOS (2005).

C20

- 30 , 46% Cl 4 ° C 4 INEOS (2005).

C 20

- 30 , 48% Cl

- 15 ° C 2 ICI (1989 ).
C20

- 30 (solid)
C20

- 30 , 70% Cl

- 30 ° C to

- 3 ° C 2 ICI (1989)
C18

- 28, 71.5% Cl 10 3

– 1 15 ° C ( soften ing point) 2 Dover (200 8c )

Boiling Point > 210

- 3 00 ° C (decomposition) UK EA (2009) Strack (1986) Actual boiling point levels cannot be det ermined as the products decompose prior to boiling. Decompos ition

occurs at > 210

- 3 00 o C. Modelled data (using MPBPWIN (ver 1.28)) on representative chloroalkane molecules have been provided. C 18 H 33 Cl 5 (41.6% Cl) ~413 ° C (estimated) 2 UK EA 2009 (modeled data)
C 18 H 30 Cl 8 ( 53.6% Cl) ~467 ° C (estimated) 2 UK EA 2009 (modeled data)
C 20 H 36 Cl 6 (43.6 % Cl) ~454 ° C (estimated) 2 UK EA 2009 (modeled data)

C 20 H 33 Cl 9 ( 53.9 % Cl) ~508 ° C (estimated) 2 UK EA 2009 (modeled data)

C 25 H 45 Cl 7 (41. 9 % Cl) ~530 ° C ( estimated) 2 UK EA 2009 (modeled data)

C 25 H 42 Cl 10 ( 50

. 9 % Cl) ~583 ° C (estimated) 2 UK EA 2009 (modeled data)
C 30 H 53 Cl 9 (4 3 .6% Cl) ~623 ° C (estimated) 2 UK EA 2009 (modeled data)
C 30 H 49 Cl 13 ( 53.0 % Cl) ~695 ° C (estimated) 2 UK EA 2009 (modeled data)

C 25 H 29 Cl 23 ( 7 1. 3 % Cl) ~827 ° C (estimated) 2 UK EA 2009 (modeled data)

C 30 H 35 Cl 27 ( 70

. 8 % Cl) ~956 ° C (estimated) 2 UK EA 2009 (modeled data) Density C18

- 20 (liquid) Ranges from approximately 0.9 to 1.3 g/mL (g/cm 3 ) at 20 o C for C18

- C20 LCCPs. C18

- 20, 20% Cl 0.923 mg/l @ 25 ° C 4 INEOS (2005).
C18

- 20, 35% Cl 1.055 g/cm 3 @ 20 ° C 4 Hoechst AG (1990).
C18

- 20, 40.5% Cl 1 .13 g/ml @ 25 ° C 4 INEOS (2005).

C18

- 20, 47% Cl 1.21 g/ml @ 25 ° C 4 Houghton (2003).OECD SIDS ALKANES, C 18

- 30 , CHLORO

9 Property Substance Value Rel. Ref. Remarks

C18

- 20, 47. 5 % Cl 1.21 g/ml @ 25 ° C 4 INEOS (2005).

Ranges from around 1.1 g/cm 3 to 1.6 g/cm 3 at 20 o C for C20

- C30 LCCPs.

The density increases with increasing chlorine
content. C18

- 20, 50% Cl 1.27 g/ml @ 25 ° C 4 Houghton (2003).
C18

- 20, 52% Cl 1.3 g/cm 3 @ 20 ° C 4 Hoechst AG (1990 ).
C18

- 20, 52.2% Cl 1.28 g/ml @ 25 ° C 4 INEOS (2005).
C20

- 30 (liquid)
C20

- 30, 37% Cl 1. 11 g/ml @ 25 ° C 4 Dover 200 8 b
C20

- 30, 39% Cl 1. 08 g/ml @ 25 ° C 4 Dover 200 8b
C20

- 30, 40% Cl 1.11 g/ml @ 25 ° C 4 Dover 200 8 b
C20

- 30, 41.5% Cl 1.16 g/m l @ 25 ° C 4 INEOS (2005).
C2 0

- 30 , 42 % Cl 1.16 g/ml @ 25 ° C 4 INEOS (2005).
C20

- 30 , 42% Cl 1.16 g/ml @ 25 ° C 4 Houghton (2003).
C20

- 30 , 42% Cl 1.1 5 g/ml @ 25 ° C 4 Dover 200 8 b
C20

- 30 , 4 3 % Cl 1.1 5 g/ml @ 25 ° C 4 Dover 200 8 b
C20

- 30, 46% Cl 1 .216 g/ml @ 25 ° C 4 INEOS (2005).
C20

- 30, 48% Cl 1.24 g/ml @ 25 ° C 4 INEOS (2005).
C20

- 30

, 4 8% Cl 1.26 g/ml @ 25 ° C 4 Houghton (2003).
C20

- 30

, 50 % Cl 1 .23 g/ml @ 25 ° C 4 Dover 200 8 b
C20

- 30 , 4 3 % Cl 1. 25 g/ml @ 25 ° C 4 Dover 200 8b
C20

- 30 (s olid)
C 18

- 28

, 71.5 % Cl 1 .62 g/ml @ 25 ° C 4 Dover 200 8c
C20

- 30 , 70% Cl 1.63 g/ml @ 25 ° C 4 Houghton (2003). Vapo u r Pressure C18

- 20 (liquid) The v apo u r pressure of LCCPs are all extremely low , though the results vary quite a bit. Variability in

measur ed values may result from the nature of these complex mixtures and difficulties measuring such low vapour
pressures. Measured values are likely to represent the vapour pressures of the most volatile components in the tested LCCP. Estimated values are based on a single representative chemical structure. modelled data using MPBPWIN (ver 1.28) estimated at 25 oC, using the following C 18 H 3 4 Cl 5 ( 41.6% Cl ) 5.3 × 10

- 4 Pa (estimated)

. 2 UK Env

. Agency (200 9 )

C 18 H 30 Cl 8 ( 53.6% Cl) 2.5 × 10

- 5 Pa (estimated) 2 UK Env

. Agency (200 9 )

C20

- 30 (liquid)

C 20 H 3 6 Cl 6 ( 4 3.6% Cl ) 5.1 × 10

- 5 Pa (estimated) 2 UK Env

. Agency (200 9 )

C 2 0 H 3 3 Cl 9 ( 54% Cl ) 2.3 × 10

- 6 Pa (estimated) 2 UK Env

. Agency (200 9 )

C23, 42

- 54% Cl 2.67 × 10

- 3 Pa @ 65 ° C 2 Howard (1975).
C 25 H 45 Cl 7 ( 41.9% Cl ) 6.3 × 10

- 7 Pa (estimated) 2 UK Env

. Agency (200 9 )

C 25 H 42 Cl 10 ( 50.9% Cl ) 2.7 × 10

- 8 Pa (estimate d) 2 UK Env

. Agency (200 9 )

C 30 H 53 Cl 9 ( 43.6% Cl ) 2.4×10

- 9 Pa (estimated) 2 UK Env

. Agency (200 9 )

C 30 H 49 Cl 13 ( 5 3% Cl ) 3.1×10

- 11 Pa (estimated) 2 UK Env

. Agency (200 9 )
C20

- 30 (solid)
C 25 H 29 Cl 23 ( 71.3% Cl ) 1.4 × 10

- 15 Pa (estimated) 2 UK Env

. Agency (200 9 )OECD SIDS ALKANES, C 18

- 30 , CHLORO

10 Property Substance Value Rel. Ref. Remarks

C 30 H 35 Cl 27 ( 70.8% Cl ) 6.1×10

- 19 Pa (estimated) 2 UK Env

. Agency (200 9 ) input melting point values:

- 25 oC for 42

– 44% Cl, 0oC for 51

– 54% Cl and 100 oC for 71% Cl LCCPs. The
vapour pressure generall y decreases with increasing carbon chain length and chlorine
content. Estimates of representative chloroalkane chemicals range from a round 5 × 10

- 4
Pa to 6.3 × 10

- 15 Pa at 25 o C for liquid LCCPs and 1.4 × 10

-
15 to 6.1 × 10

- 19 at 25 o C for solid LCCPs.

Partition coefficient n

octanol/water (log value) C18

- 20 (liquid) Modelled data developed using KOWWIN (ver 1.6). Ranges from around 7.5 to ~2 0. The log Kow
gener ally increases with increasing carbon chain length and chlorine
content. C 18 H 34 Cl 5 (41.6% Cl) 10.2 (estimated) 2 UK Env

. Agency (200 9 )

C 18 H 30 Cl 8 ( 53.6% Cl) 10.7 (estimated) 2 UK Env

. Agency (200 9 )

C18

- 26, 44% Cl 7.46

– 11.48 2 Renberg (1980).
C20

- 30 (liquid)
C 20 H 36 Cl 6 (43.6% Cl) 11.3 (estimated) 2 UK Env

. Agency (200 9 )

C 20 H 33 Cl 9 (54% Cl) 11.9 (estimated) 2 UK Env

. Agency (200 9 ).

C21.5 (average)

, 42% Cl 7.63

– 12.83 2 Renberg (1980).

C22

- 26, 42% Cl, 9.29

– >12.83 2 Renberg (1 980).
C22

- 26, 48% Cl 8.69

– 12.83 2 Renberg (1980).

C 25 H 45 Cl 7 (41.9% Cl) 14.0 (estimated) 2 UK Env

. Agency (200 9 ).

C 25 H 42 Cl 10 (50.9% Cl) 14.5 (estimated) 2 UK Env

. Agency (200 9 ).

C 30 H 53 Cl 9 (43.6% Cl) 16.8 2 UK Env

. Agency (200 9 ).

C 3 0 H 49 Cl 13 (53% Cl) 17.5 2 UK Env

. Agency (200 9 ).
C20

- 30 (solid)
C 25 H 29 Cl 23 (71.3% Cl) 16.9 2 UK Env

. Agency (200 9 ).

C 30 H 35 Cl 27 ( 70.8% Cl ) 20.1 2 UK Env

. Agency (200 9 ).

Water C18

- 20 (liquid) E stimated values from the UK EAOECD SIDS ALKANES, C 18

- 30 , CHLORO

11 Property Substance Value Rel. Ref. Remarks

Solubility C 18 H 34 Cl 5 (41.6% Cl) 0.017

- 6.1 ug/l ( estimated; input log Kow 10.16 & 7.5) 2 UK Env . Agency (200 9 ). were d eveloped using WSKOW (ver 1.3) and have been calculated using 2 different selected log Kow values as inputs, one the estimated value from KOWWIN and the other from the lower end of the measured log Kow data. The upper limits from the estimates are reasonab ly consistent with the measured data . All values were about 5 μg/l or lower at 25 o C. The water solubility generally decreases with increasing carbon chain length. C20

- 30 (liquid)

C 25 H 45 Cl 7 (41.9% Cl) 1.6 × 10

- 6

- 2.0 μg/l ( estimated; input log Kow 13.96 & 7.6) 2 UK Env. Agency (200 9 ).

C25 (average) 43% Cl ≤ 6.4 ug/l @ 20 ± 2 ° C 2 Madeley & Gillings (1983 ).

C20

- 30 (solid)
C 18

- 28

, 71.5 % Cl 0.0066 mg/L @ 2 0 ° C 2 Dover 200 7
C25 (average) 70% Cl ≤ 5.9 ug/l @ 20 ± 2 ° C 2 Madeley & Gillings (1983).
C 25 H 29 Cl 23 (71.3% Cl) 1.6×10

- 11

- 1.0×10

- 8 μg/l ( estimated; input log Kow 16.92 & 14) 2 UK Env. Agency (200 9 ).

Flash Point C20

- 30 (liquid)
C 18

- 28

, 43 % Cl > 210 °C 2 Dover 2008a
C20

- 30, 39

- 50% Cl >232 °C 2 Dover 200 8b

Viscosity C18

- 20 (liquid)
C18

- 20 , 47% Cl 1

. 7 Pa·s @ 25 ° C 2 Houghton (2003).

C18

- 20 , 50% Cl 1

. 8 Pa·s @ 25 ° C 2 Houghton (2003).
C20

- 30 (liquid)
C20

- 30

, 39

- 40 % Cl 0.3

- 0.8 Pa s @ 25 ° C 2 Dover 200 8a

C20

- 30

, 37

- 49 % Cl 0.8

– 29.5 Pa s @ 25 ° C 2 Dover 200 8b

C20

- 30 , 42% Cl 2

. 5 Pa s @ 25 ° C 2 Houghto n (2003).

C20

- 30

, 42

- 51 % Cl 2.9

- 37.5 Pa s @ 25 ° C 2 Dover 2007

C20

- 30 , 48% Cl 2 8 Pa s @ 25 ° C 2 Houghton (2003).

C20

- 30, 42% Cl 22 Pa·s @ 25 ° C
3.2 Pa·s @ 50 ° C 2 Campbell (1980).

C20

- 30 (solid)
C20

- 30 , 70% Cl Solid; softening point =
95

- 100 ° C 2 Houghton (2003).

The data presented in T able 1 and their trends have been used to select the following representative values for physico

- chemical endpoints used further in this assessment (environmental fate and behaviour modelling) for the thr ee sub

- groups of LCCPs:

Vapour pressure ( at 25 o C ) : C 18

- 20 liquid (ca. 40

– 52% Cl) : 2.5 × 10

- 4 Pa C 20

- 30 liquid (ca. 40

– 54% Cl) : 2.5 × 10

- 5 PaOECD SIDS ALKANES, C 18

- 30 , CHLORO

12 C 20

- 30 solid (ca. 70% Cl) : 1.5 × 10

- 14 Pa for LCCPs.

Water Solubility : 5 ug/l for all LCCPs

Log Kow : C 18

- 20 liquid (ca. 40

– 52% Cl) : 9.7 C 20

- 30 liquid (ca. 40

– 54% Cl) : 1 0.3 C 20

- 30 solid (ca. 70% Cl) : 17

1.4 Category Justification

The Long

- Chain Chlorinated Paraffins (LCCP) category contain s complex commercial substances whose chemical components are predomi nantly in the range of carbon chain lengths from C 18 to C 30 and whose chlorine contents are approximately 35

- 70% by weight

. Alkyl chains of the constituents are always primary, and each of their carbon atoms never contain s more than one chlorine substitu ent

. T he substances in this category have a predictable range of physico

- chemical propert ies and physical forms based primarily on degree on chlorination

. As chain length and degree of chlorination increases, so do pour (melting) points and octanol

- water partition coefficients; water solubilities decrease with increasing chain length

. The data in this SIAR are presented based on carbon

- chain length, chlorine content, and physical form in order to fully compare and array the data for each type of substanc e within the category. As a consequence of differing use patterns depending on physical form, degree of chlorination and chain length, the category is sub

- divided into three groups: C 18

- 20 liquid, C 20

- 30 liquid and C 20

- 30 solid LCCPs (see Identity section ). C 18

- 20 LCCPs are produced from an n

- alkane fe edstock with chain lengths centred around C 18/19 , whereas C 20

- 30 LCCPs are made from an n

- alkane feedstock centred around C 24/25 ; whether the latter are categorised as liquid or solid depends on the degree of chlorination. However, they appear to exhibit similar environmental fate and toxicology data, which support these substances being included in the same category. Further, while there are ranges to the physic

chemical properties LCCPs all still display si milar characteristics

– very low water solubility, low vapour pressure, and high K ow values. Environmental fate modelling indicates that all LCCPs are anticipated to partition almost entirely to the soil or sediment depending on release patterns indicati ng that exposure patterns will likely be very similar for all LCCPs

.
Data from the related substance MCCPs are used to fill endpoints in the assessment of human health hazards for C 18

- 20 LCCPs. C 18

- 20 LCCP data gaps exist for oral acute toxicity, irritat ion, oral repeated dose toxicity, toxicity for reproduction (effects on fertility) and developmental toxicity. MCCPs, as described in the Identity section, have carbon chain lengths between C 14 and C 17 and are similar in physico

- chemical properties to C 18

- 20 LCCPs, so this approach seems justified.



### 2 GENERAL INFORMATION ON EXPOSURE

2.1 Production Volumes and Use Pattern

LCCPs are produced by the direct chlorination of n

- paraffin feedstocks predominantly in the range of C 18

- 3 0 , with the main commercial products b eing in the range of C 2 0

- 30 and a smaller class of products in the C 18

- 20 range. T he precise carbon

- chain distribution for an individual product will vary depending on the petroleum oil source. LCCPs are manufactured at a handful of locations in the E uro pean U nion , U nited S tates , and elsewhere globally, but there is currently no manufacturing site in the United Kingdom ( CPIA, EuroChlor, UK EA , 200 9 )

. The global production of LCCPs is estimated to be >300,000 tonnes/year.OECD SIDS ALKANES, C 18

- 30 , CHLORO

13 The total EU usage of LCCPs ha s been in the range of 5,000

- 10 ,000 tonnes/year from 19 98

- 2004 ( Euro Chlor, 2000 and 2005 ). The main areas of use of LCCPs are as a secondary plasticiser in PVC, as a flame retardant in rubber and textiles, as a plasticiser/flame retardant in sealants/adh esives and paints, as an extreme pressure additive to metal cutting/working fluids and as a component of leather fat liquoring treatments (UK EA, 200 9 ). In very general terms, the chlorinated paraffins with chlorine contents in the range 40

- 50% wt Cl are used in plasticising applications, whereas the chlorinated paraffins with very high chlorine contents (e.g. 70% wt Cl) are used mainly as flame retardants (Zitko and Arsenault, 1974). T he relative use in each application in the EU for 2004 is shown in Figu re 2

. Figure 3 also shows the total use of LCCPs in Nordic countries from the SPIN database (search of CAS 63449

- 39

- 8 on www.spin2000.net).

Rubber

Paints Sealants/adhesives Metal cutting/working Leather PVC Other Textiles Figure 2: Uses of long

- chain chlorinated paraffins in the EU

Source: UK EA ( 200 9 )

Figure 3 : Total use of LCCPs in the Nordic Countries (tonnes /year)OECD SIDS ALKANES, C 18

- 30 , CHLORO

14 Source: SPIN Database f or CAS number 63449

- 39

- 8 (2008)

2.2 Environmental Exposure and Fate

2.2.1 Sources of Environmental Exposure

There are no known natural sources of LCCPs. LCCPs may enter the environment, principally as emissions to water duri ng their manufacture and transportation, during their incorporation into downstream products (PVC, metal working fluids, sealants, rubber, leather fat liquors, paints, textiles) and their processing, especially at high temperatures, and during the use and final disposal of these products.

The predicted fate of LCCPs in waste

- water treatment plants is that the vast majority will be adsorbed onto industrial sewage sludge and the remainder (<10%) will be released to surface water in the effluent from the plan t.

Although LCCPs have very low vapour pressures, minor emissions to air may occur from sources with elevated temperatures (e.g. during polymer processing). Minor emissions may also occur over the lifetime of products (e.g. polymers, paints, sealants) c ontaining LCCPs, although the rate and amount of loss is expected to be minimal

.

2.2.2 Photodegradation

In air, a chemical can react with photosensitized oxygen in the form of • OH or with ozone. These reactions are characterized as indirect photodegradation, an d can result in a parent chemical's degradation in the atmosphere. LC CPs react with • OH in air to degrade , but react at a negligible rate with ozone. Therefore, photolysis as a result of hydroxyl radical attack will contribute significantly to the physical degradation of these chemicals in the atmosphere, but reactions with ozone will not contribute to their loss from the environment.

L CCPs s econd order rate constants (k OH ) for the indirect photodegradation reaction were estimated from chemical structure u sing the Syracuse Research Corporation AOP (version 1.86; the program is based on the Atkinson method), and example calculations have been given in Table 2 . The estimated atmospheric half

- lives are based on an atmospheric hydroxyl radical concentration of 5 x 10 5 • OH /cm 3

.OECD SIDS ALKANES, C 18

- 30 , CHLORO

15 The estimated atmospheric half

- lives range from 18 to 112 hours. The half

- li ves are inversely related to carbon chain length as they decrease with increasing carbon chain length , but are directly related to chlorine content as they increase with increasing chlorine content.OECD SIDS ALKANES, C 18

- 30 , CHLORO

16 Table 2 : Estimated atmospheric half

- lives for long

- chain chlorinated paraffins

Formula Chlorine content (% wt. Cl) k OH (cm 3 /molecule s) Atmospheric half

- life

C 18 H 33 Cl 5 41.6 1.27×10

- 11 30.3 hours C 18 H 30 Cl 8 53.6 9.83× 10

- 12 39.2 hours C 20 H 36 Cl 6 43.6 1.47×10

- 11 26.2 hours C 20 H 33 Cl 9 53.9 1.05×10

- 11 36.7 hours C 25 H 45 Cl 7 41.9 1.88×10

- 11 20.5 hours C 25 H 42 Cl 10 50.9 1.53×10

- 11 25.2 hours C 25 H 29 Cl 23 71.3 3.43×10

- 12 112 hours C 30 H 53 Cl 9 43.6 2.14×10

- 11 18.0 hours C 30 H 49 Cl 1 3 53.0 1.79×10

- 11 21.5 hours C 30 H 35 Cl 27 70.8 5.51×10

- 12 69.9 hours

In comparison, direct photochemical degradation occurs through the absorbance of solar radiation by a chemical substance. If the absorbed energy is high enough, then the resultant excit ed state of the chemical may undergo a transformation. A prerequisite for direct photodegradation is the ability of one or more bonds within a chemical to absorb ultraviolet (UV)/visible light in the 290 to 750 nm range. Light wavelengths longer than 750 nm do not contain sufficient energy to break chemical bonds, and wavelengths below 290 nm are shielded from the earth by the stratospheric ozone layer. An approach to assessing the potential for a substance to undergo photochemical degradation is to

assum e that degradation will occur in proportion to the amount of light absorbed by the chemical at wavelengths >290 nm (Zepp and Cline, 1977). LCCP constituents do not absorb light within a range of 290 to 750 nm. Therefore, photolysis is not expected to contr ibute to the degradation of category members in the environment.

2.2.3 Stability in Water
There is no evidence that LCCPs are subject to hydrolysis. LCCPs do not contain any functional groups which are likely to hydrolyse.

2.2.4 Transport between Environmental Compar tments
The high log K ow values of LCCPs indicate that they would adsorb strongly onto sludge and sediments and would not be expected to be mobile in soil.
Estimated Henry’s law constants (H) are provided in Table 3 below, as estimated from Syracuse Researc h Corporation’s Henry (version 3.00) program, which estimates Henry’s law constant via a bond 

### contribution method, a group contribution method, and an “experimental value adjusted” (EVA) method (UK Environment Agency, 200 9 ). Koc values used in these calcu lations were estimated using Syracuse Research Corporation’s PCKOC (version 1.63)
program.OECD SIDS ALKANES, C 18

- 30 , CHLORO

17 Table 3 : Estimated Henry’s Law Constants

Formula Chlorine Content (% wt Cl) Bond Contribution Method Group Contribution Method EVA method (four estimates)

C 18 H 33 Cl 5 41.6 5,005 0.084 210, 60, 16, 155 Mean = 110 ± 88

C 18 H 30 Cl 8 53.6 219 1.2 x 10

- 6 9.2, 2.6, 0.7, 6.7 Mean = 4.8 ± 3.9

C 20 H 36 Cl 6 43.6 3,101 0.004 131, 37, 10, 96 Mean = 69 ± 55

C 20 H 33 Cl 9 53.9 136 6.1 x 10

- 8 5.7, 1.6, 0.4, 4.2 Mean = 3.0 ± 2.4

C 25 H 45 Cl 7 41.9 4,509 5.7 x 10

- 4 189, 54, 15, 140 Mean = 100 ±79

C 25 H 42 Cl 10 50.9 198 8.4 x 10

- 9 8.3, 2.4, 0.6, 6.1 Mean = 4.4 ± 3.5

C 25 H 29 Cl 23 71.3 2.5 x 10

- 4 8.6 x 10

- 30 1.06 x 10

- 5 , 3.0 x 10

- 6

, 8.2 x 10

- 7 , 7.9 x 10

- 6 Mean = 5.6 x 10

- 5 ± 4.5 x 10

- 6

C 30 H 53 Cl 9 43.6 2,310 1.9 x 10

- 6 97, 28, 7.5, 72 Mean = 51 ± 41

C 30 H 49 Cl 13 53.0 35.6 7.0 x 10

- 13 1.5, 0.4, 0.1, 1.1 Mean = 0.8 ±0.6

C 30 H 35 Cl 27 70.8 1.6 x 10

- 5 1.8 x 10

- 35 6.8 x 10

- 7 , 1.9 x 10

- 7

, 5.2 x 10

- 8 , 5.0 x 10

- 7 Mean = 3.6 x 10

- 7 ± 2.9 x 10

- 7



### Estimated organic carbon

- wat er partition coefficient ( K OC 

### ) values for long

- chain chlorinated paraffins are provided in Table 4 below (UK Environment Agency, 200 9 )

.

Table 4: Estimated K OC values for long

- chain chlorinated paraffins from structure

Formula Chlorine Content (% wt Cl) K OC (l/kg)

C 18 H 33 Cl 5 41.6 2.93 x 10 6
C 18 H 30 Cl 8 53.6 1.27 x 10 7
C 20 H 36 Cl 6 43.6 1.61 x 10 7
C 20 H 33 Cl 9 53.9 7.00 x 10 7
C 25 H 45 Cl 7 41.9 5.58 x 10 8
C 25 H 42 Cl 10 50.9 2.42 x 10 9
C 25 H 29 Cl 23 71.3 1 x 10 10 a
C 30 H 53 Cl 9 43.6 1 x 10 10 a
C 30 H 49 Cl 13 53.0 1 x 10 10 a
C 30 H 35 Cl 27 70.8 1 x 10 10 a

a = upper limit of estimation method.OECD SIDS ALKANES, C 18

- 30 , CHLORO

18 

### Distribution

– The potential environmental distribution of long

- chain chlorinated paraffins has been studied using a generic level III fugacity model (EQC version 1.01, May 1997), a summary of which is provided in Table 5 below (UK Environment Agency, 200 9 ).

Table 5 : Results of level III fugacity modeling for long

- chain chlorinated paraffins

Release Compartment Percent Distribution

Air Water

C 18

- 20 liquid C 20

- 30 liquid C 20

- 30 solid C 18

- 20 liquid C 20

- 30 liquid C 20

- 30 solid

100% to air 1.14 x 10

- 3 % 4.45 x 10

- 4 % 3.68 x 10

- 4 % 3.40 x 10

- 3 % 3.35 x 10

- 3 % 3.34 x 10

- 3 %

100% to water 7.12 x 10

- 6 % 2.78 x 10

- 7 % 8.08 x 10

- 24 % 0.853 % 0.857 % 0.858 %

100% to soil 7.05 x 10

- 8 % 2 .35 x 10

- 9 % 6.37 x 10

- 24 % 3.01 x 10

- 3 % 3.01 x 10

- 3 % 3.01 x 10

- 3 %

50% to air + 50% to water 1.12 x 10

- 3 % 4.41 x 10

- 4 % 3.66 x 10

- 4 % 0.018 % 0.012 % 8.45 x 10

- 3 %

Release Compartment Percent Distribution

Soil Sediment

C 18

- 20 liquid C 20

- 30 liquid C 20

- 30 solid C 18

- 20 liquid C 20

- 30 liquid C 20

- 30 solid

100% to air 99.6 % 99.6 % 99.6 % 0.393 % 0.387 % 0.386 %

100% to water 0.625 % 0.062 % 2.19 x 10

- 18 % 98.5 % 99.1 % 99.1 %

100% to soil 99.6 % 99.6 % 99.6 % 0.348 % 0.348 % 0.348 %

50% to air + 50 % to water 97.9 % 98.6 % 99.0 % 2.06 % 1.35 % 0.976 %

2.2.5 Biodegradation

While there is n o current OECD guideline study for ready or inherent biodegradation , t here are a variety of available data on the biodegrada bility of LCCPs

. LCCPs are considered not to b e readily biodegradable. The results indicate some potential for bio degradation with acclimated microorganisms , but limited biodegradation in non

- acclimated organisms

. The potential for biodegradation appears to increase with decreasing chlorine content. There is also some evidence that biodegradation may occur under anaerobic conditions.

The biodegradation of a C 20

– 30 , 42% wt Cl product has been determined in a prolonged test Biochemical Oxygen Demand (BOD) (Madeley and Birtley, 1980)

– determined to have a reliability of 2 . The test was carried out using an emulsion of the chlorinated paraffin. Two microbial populations were used in t he study: firstly a culture from soil collected close to a CP production plant that was acclimatised over an eight wee k period to a concentration of 20

– 50 mg/l of the CP ; and secondly, a non

- acclimatized culture obtained from the effluent of a laboratory activated sludge unit treating domestic sewage. Re sults were based on comparing BOD to the theoretical oxygen demand (T hOD) and showed 7.5% biodegradation after 25 days for non

acclimated organisms and 23% biodegradation after 25 days for acclimated organisms.OECD SIDS ALKANES, C 18

- 30 , CHLORO

19 To investigate the potential for degradation further, Madeley and Birtley (1980) carried out a series of experime nts using a 14C

- labelled pentacosane (radiolabelled on the central carbon) mixed with the same C 20

– 30 , 42% wt Cl product in Hach respirometers with non

- acclimated microorganisms. After eight weeks incubation, around 11 % of the 14C was collected as 14CO 2 , i ndicating that where degradation had occurred it was extensive enough to release the central carbon atom of the C 25 chain. In addition to the above studies, Madeley and Birtley (1980) also reported preliminary studies investigating the degradation of the C 20

– 30 , 42% wt Cl product under anaerobic conditions. The anaerobic bacteria were obtained from anaerobic sludge digesters. Gas production (methane and CO 2 ) in the presence of increasing quantities of an emulsion of the CP was determined over 30 days and c ompared with controls. No significant increase or decrease in bacterial activity was seen at concentrations of the CP of up to 10 % by weight of dry sludge solids. It was concluded that the substance was not toxic to the bacterial population present but al so was not actively degraded under these conditions.

Additional biodegradation results by Hildebrecht (1972) , reliability 2, were reported by Howard et al. (1975) , though the reliability of these data has been questioned as the test systems appear to have contained additional carbon sources that may have been biodegradable under the conditions of the
test (UK EA 2009). In this study, the biodegradability of a C 20

- 30 , 42% wt Cl LCCP and a C 20

- 30 , 70% wt Cl LCCP were evaluated using oxygen consumption over 20 hours in a Warburg respirometer or over five days using a BOD method. The sewage seed used was acclimated to up to 100 mg/l of chlorinated paraffins before use in the test. The results obtained are shown in the table below.

Table 6 : Biodegradation Re sults Reported by Hildebrecht (1972) Substance Formulation Tested Warburg R espirometry BOD dilution method Oxygen Consumption (mg/L) Degradation * BOD (mg/L) Degradation *

C20

- 30, 40

– 42% Cl 500 mg/ L of a mixture containing 75% LCCP, 5% surfactant and 20%
water. 83 17.2% 120 25%

C20

- 30, 70% Cl 500 mg/L of a mixture containing 37.5% LCCP, 37.5% perchloroethylene, 5% surfactant and 20% water. 298 17.2% 30 2%

Surfactant 500 mg/L surfactant 377 46.5% 530 65%

*Deg radation was estimated by the authors as the percentage of the theoretical oxygen demand based on the total carbon content of the test solution. Substances other than the chlorinated paraffin contribute to this total carbon content.

Hoechst AG (1976 and 1977) reported five

- day biochemical ox ygen demand (BOD5) values for several products: C 18

– 20 , 35% Cl , C 18

– 20 , 44% Cl, C 18

– 20 , 49% Cl and C 18

– 20 , 52% Cl . Unfortunately, the reliability of these studies could not be assigned (reliability 4) because f ew details of how the tests were carried out are given. The results show little or no biodegradation when compared with the measured chemical oxygen demand (COD) values.OECD SIDS ALKANES, C 18

- 30 , CHLORO

20 There is some evidence that LCCPs may be subject to biodegradation in sea water/estuarine sediment (Zitko & Arsenault, 1974 & 1977 ). It is not possible to derive any biodegradation rates applicable to the marine environment from these data.

2.2.6 Bioaccumulation
LCCPs have been shown, experimentally, to bioaccumulate in fish and mussels. Much of the data was obtained using exposure concen trations well in excess of the water solubility of the substance tested and it is not possible to obtain a reliable BCF value from them. The potential for uptake and accumulation of the substance by fish and other aquatic and terrestrial organisms is unce rtain, but appears to decrease with increasing carbon chain length and increasing degree of chlorination. The model estimated BCFs in fish for the LCCP are as follows ( method taken from the EU Technical Guidance Document parabolic equation, application fo r substances with log Kow >6 and molecular weight < 700 g/mol: log BCF =

- 0.2 x(log Kow) 2 + (2.74 x log Kow

– 4.72)) :

C 18

- 20 liquid LCCP BCF = 1,096 L /kg C 20

- 30 liquid LCCP BCF = 192 L /kg C 20

- 30 solid LCCP BCF <1 L /kg

There is evidence from fe eding studies that LCCPs can be taken up via the diet, but in all cases the concentrations reached in the animals were less than those in the diet. This indicates that although uptake of the substance can occur via the food, the levels should not increase through the food chain (UK EA 2009)

.
Based on estimates of BCF taking the known accumulation properties of structurally similar substances into account

, the BCF for LCCPs is considered to be <2,000 L /kg (UK EA , 2009). Thus it is concluded that LCCPs are unlikely to meet the B or vB (very bioaccumulative) EU criteria.

2.2.7 Other Information on Environmental Fate

2.3 Human Exposure

2.3.1 Occupational Exposure

Occupational exposure to LCCPs may occur during their manufacture, their incorporation into downstream products (PVC, metal working fluids, sealants, rubber, leather fat liquors, paints, textiles) and their processing, especially at high temperatures and during the use of these products.
LCCPs are either viscous liquids with very low vapour pressures or solids. The exposure route of greatest significance is by inhalation of aerosols during the use of liquid products such as metal

working fluids, of vapours during high temperature processing (e.g

., of PVC) or of the dusts from the solid grades. The aerosols from the p roducts containing liquid grades also have the potential to come into contact with the skin, although this route is regarded as being insignificant.

2.3.2 Consumer Exposure
LCCPs and products which contain them are not supplied directly to the consumer. A searc h of the U.S. Household Products Database, a comprehensive database of chemical ingredients in household products maintained by the U.S. National Library of Medicine, found no consumer products containing LCCPs (U.S. NIH 2008).OECD SIDS ALKANES, C 18

- 30 , CHLORO

21 

### 3 HUMAN HEALTH HAZARDS

3.1 Effects on Human Health
This assessment considers the available mammalian toxicity data on LCCPs, which includes a significant amount of data for most health endpoints. In a few cases were data are limited, additional data on other chain length CPs (e.g., MCCPs) have been considered. In particular, data on MCCPs have been used to help characterise the effects of the C 18

- 20 subgroup for acute, repeat

dose and reproductive endpoints

.

3.1.1 Toxicokinetics, Metabolism and Distribution
As part of a 90

- day repeat

- dose toxi city study on a C 22

- 26 , 43 % Cl, groups of 25 male and 25 female F344 rats that had previously received either 100 or 3750 mg/kg bwt/day of test compound by gavage, were given by gavage single doses of 100 and 3750 mg/kg bwt 14 C chlorinated pentacosane (43 .2% w/w Cl), respectively, at the end of their exposure period ( IRDC, 198 4 b ). In addition, groups of 18 male and 18 female naïve F344 rats received the same doses of radiolabelled compound.
The vast majority of radiolabel was recovered in the faeces, rang ing from 82.3% to 95.7% after 7 days in all groups of naïve rats, suggesting that the compound was either poorly absorbed or that a significant quantity was excreted in the bile, either unchanged or metabolised. Small quantities of radioactivity were found in the urine (ranging from <0.1% to 0.8% after 7 days in all groups of naïve rats) and in expired air (ranging from <0.1% to 0.4% after 7 days in all groups of naïve rats). Up to 4.3% of the radioactivity was found in the tissues 7 days after administrati on of the radioactive dose. The highest levels were found in liver, 12 hours after dosing with 3750 mg/kg bwt (pre

- treated males

– 568 +/

- 119 ppm: pre

- treated females

- 1682 +/

- 281 ppm). Levels of the order of one order of magnitude less were found in adi pose tissue and the kidney, peaking 7 to 28 days after administration and declining significantly over the next 9 weeks. High levels (232 +/

- 121 ppm in the high dose pre

- treated group) were also found in the ovaries 7 days after administration of the
test dose. Blood levels tended to peak 12 to 24 hours after administration of the test dose and declined significantly over the first seven days.
A similar study ( IRDC 1984a ) was reported as part of a 90

- day repeat dose toxicity study in which a C 22

- 28 , 70% Cl LCCP was administered via the diet. The study design was the same, as were the doses administered. The radiolabelled compound, a 14 C chlorinated pentacosane (70% w/w Cl) was administered by gavage.
The elimination of radioactivity and distribution and eli mination of residual radioactivity showed a very similar pattern to that described in the previous experiment, with the majority of radioactivity being recovered in the faeces and residual radioactivity being found primarily in the liver. Distribution and elimination from adipose tissue was again slower than for other compartments. Radioactivity was also seen in the ovaries, but to a lesser extent than with the 43% Cl compound.
Given the inconclusive nature of these absorption results, a default assumption is that 50% of the oral dose is absorbed.OECD SIDS ALKANES, C 18

- 30 , CHLORO

22 3.1.2 Acute Toxicity

Studies in Animals

Inhalation
No acute toxicity studies are reported in which LCCPs have been administered by inhalation.

Dermal
No acute toxicity studies are reported in which LCCPs have been admin istered by the dermal route.

Oral
LCCPs are of low acute toxicity following oral administration. Table 7 summarizes the acute oral toxicity data for LCCPs. Valid studies in the rat, mouse, and dog have been reported on both liq uid and solid LCCPs in the C 20

- 30 range. The most consistent observation made during the post

exposure period was evidence of faecal incontinence, presumably associated with the large volume of test material administered. No mortalities were observed and all studies reported LD 50 values > 5.0 g/kg bwt.

No valid studies have been conducted on a C 18

- 20 liquid grade LCCP. However, the fact that C 14

- 17 CPs also have high LD 50 values (i.e. > 2.0 g/kg bwt) suggests that this type of LCCP would have a similar low acute toxicity 

### (UK Enviro nment Agency, 2009 ).

Table 7 : Acute Toxicity

SUBSTANCE ROUTE SPECIES VALUE REL. REFERENCE C20

- 30 (liquid)
C22

- 26; 42% Cl O ral rat LD 50 > 10 ml/kg bw 2 Chater and Jaggers (1978). C22

- 26; 42% Cl O ral rat LD 50 > 5000 mg/kg bw 2 ICI (1963). C23 (average) ; 43% Cl O ral rat LD 50 > 11700 mg/kg bw 1 NTP (1986). Bucher (1987). C20

- 30; 41

- 50% Cl O ral rat LD 50 > 10,000 mg/kg bw 2 Birtley (1980). C20

- 30; 51

- 60% Cl O ral rat LD 50 > 10,000 mg/kg bw 2 Birtley (1980). C20

- 30; 61

- 70% Cl O ral rat LD 50 > 10,000 mg/kg bw 2 Birtley (1980). C23 (average) ; 43% Cl O ral mouse LD 50 > 23400 mg/kg bw 1 NTP (1986). Bucher (1987).

C22

- 30; 42% Cl O ral mouse LD 50 > 5000 mg/kg bw 2 ICI (1963). C22

- 30; 42% Cl O ral dog LD 50 > 5000 mg/kg bw 2 ICI (1963).

C20

- 30 (solid)
C22

- 30; 70 % Cl O ral rat LD 50 > 5000 mg/kg bw 2 ICI (1964). C22

- 30; 70% Cl O ral rat LD 50 > 5000 mg/kg bw 2 ICI (1963). C22

- 30; 70% Cl O ral mouse LD 50 > 5000 mg/kg bw 2 ICI (1963). C22

- 30; 70% Cl O ral dog LD 50 > 5000 mg/kg bw 2 ICI (1963).

Conclusion

LCCPs demons trate a low order of acute toxicity. No mortalities were observed and the reported oral LD 50 values all exceeded 5,000 mg/kg bwt in the rat, mouse and dog. This conclusion is also supported by additional acute intraperitoneal (i.p.) stud ies in rats and m ice that showed no mortality
at 5,000 mg/kg bwt (i.p.) with several different LCCP test substances . The lack of acute toxicology data via inhalation or dermal exposure routes for LCCPs is not expected to be an important data gapOECD SIDS ALKANES, C 18

- 30 , CHLORO

23 as these routes of exposur e are insignificant for LCCPs, which have very low vapour pressure and are absorbed very poorly through the skin.

3.1.3 Irritation

Skin Irritation

Studies in Animals

Valid studies have been conducted on a C 22

- 26 liquid LCCP in rabbits and rats and also on severa l C 20

- 30 liquid LCCP s in rats. All results were not irritating in rats and slight ly irritati ng in the rabbit for C 22

- 26 , 42% Cl.

Table 8 : Skin Irritation SUBSTANCE SPECIES RESULT REL. REFERENCE C 20

- 30 (liquid)
C22

- 26; 42% Cl R abbit slightly irritating 2 Chater and Jaggers (1978). C20

- 30; 41

- 50% Cl R at not irritating 2 Birtley (1980). C20

- 30; 51

- 60% Cl R at not irritating 2 Birtley (1980). C20

- 30; 61

- 70% Cl R at not irritating 2 Birtley (1980). C22

- 26; 42% Cl rat not irritating 2 Chater and Jaggers (1978)

Eye Irritation

Studies in Animals

Two studies in rabbits have been conducted on C 20

- 30 liquid LCCPs and one on a solid C 22

- 30, 70% Cl LCCP

. The results from these studies are reported in Table 9 and include both non

- irritating and slightly

- irritat ing effect s for the products

.

Table 9 : Eye Irritation SUBSTANCE SPECIES RESULT REL. REFERENCE C20

- 30 (liquid)
C20

- 30; 61

- 70% Cl rabbit not irritating 2 Birtley (1980). C22

- 26; 42% Cl rabbit slightly irritating 2 Chater and Jaggers (1978) C20

- 30 ( solid)
C 22

- 30, 70% Cl rabbit Slightly irritating 2 ICI (1964)

Respiratory Tract Irritation

Studies in Animals
There are no studies on the respiratory tract irritant effects of LCCPs , thou gh given their very low
vapour pressure , inhalation exposure is an ticipated to be minimal.

Conclusion
LCCP have been shown to be, at most, only slightly irrita t ing to the skin and eyes in experimental animals. Skin and eye irritation have been investigated in animal studies for a number of LCCP products. These studies s uggest that LCCPs have the potential to cause slight irritation

.OECD SIDS ALKANES, C 18

- 30 , CHLORO

24 Single exposure to MCCPs also caused slight irritation in standard tests, but somewhat more pronounced irritation has been reported following repeated exposure, presumably due to defatting properties. The UK has advocated (UK, 2009) that i n the absence of studies on repeated application of LCCPs to skin , a conservative assumption is made that the C 18

- 20 LCCPs could have a similar effect.

There are no specific data on respiratory tract ir ritation, but on the basis of the low skin and eye irritation potential it is anticipated that the LCCP products are unlikely to cause such an effect. Further, the potential for exposure to the respiratory tract is likely to be minimal given the very low

v apour pressure of LCCPs.

3.1.4 Sensitisation

Studies in Animals

Skin

C 22

- 26, 42% Cl liquid grade LCCP was tested for skin sensitisation using intradermal injection of a 5 % solution of the LCCP in olive oil followed 7 days later by a topical application of 20% LCCP in olive oil

. Erythema and oedema were scored 24 and 48 hours post application and n o evidence for sensitisation of the skin was reported ( Chater and Jaggers , 1978).

Several additional sensiti s ation studies have also been reported for LCCPs, includ ing the study by Bailey and Sheldon (1998) that reported no evidence of sensiti s ation in Buehler guinea pig s test ed with a C22

– 26 product (chlorination level not reported ) and a study Huels ( 198 5 ) of a C18

– 27

, 40% chlorination product , which elicited a pos itive response . The results from Bailey and Sheldon (1998) are available only as an SOT abstract, so the details and validity of this study are uncertain. The only information on the Huels ( 198 5 ) is from a limited entry from the original IUCLID file and while it reports a positive finding, many studies of this period did not account for the presence of stabiliser s that were known sensitiser s . As no details are available on this study it is impossible to make any determinations about t he test substance. In addition, data on SCCPs and MCCPs indicate that these substances are not sensitisers (IPCS 1996)

.
Respiratory Tract

There are no relevant data available.

Conclusion

The valid available data indicate that LC CPs do not cause skin sensitisation.

3.1.5 Repeated Dose Toxicity

Studies in Animals

Inhalation
No repeated dose toxicity studies are reported in which LCCPs have been administered by inhalation.

Dermal
No repeated dose toxicity studies are reported in which LCCPs have been administered by the dermal route.OECD SIDS ALKANES, C 18

- 30 , CHLORO

25 Oral

Valid repeat dose studies in the rat and mouse have been conducted via the oral route on solid and liquid LCCP products as summarized below in Table 10

.
Repeat dose toxicity studies have been conducted on a C 23 (average), 43% Cl, a C 22

- 26 , 43 % Cl a nd a C 22

- 28 , 70% Cl LCCP product in the F344 rat and, with the C 23 (average) 43 % Cl product, in the B6C3F1 mouse. The chemicals were administered either by gavage or in the diet at doses up to 3750 mg/kg bwt/day (rat) or 7500 mg/kg bwt/day (mouse). These studies include shorter duration 1

- 2 week studies, several 13 week subchronic studies, and two chronic studies conducted by the U.S. National Toxicology Program (NTP) in both the rat and mouse.

In the rat, LCCPs caused pathological evidence of liver toxi city (granulomatous inflammation), with females being more sensitive than males. Liver enzymes were measured in one study and alanine aminotransferease activity was increased in both sexes. In the study with the C 22

- 26 , 43 % Cl LCCP, there was also evidenc e of kidney toxicity, with mild nephrosis being seen in the males receiving the highest dose employed (3750 mg/kg bwt/day).

In the mouse, administration of the C 23 , 43 % Cl LCCP caused no effects on body or organ weights, no clinical signs of toxicity an d no treatment

- related histopathological effects.

The overall LOAEL for LCCPs in the 90

- day studies in the rat was 900 mg/kg bwt/day in males and 100 mg/kg bwt/day in females, based on hepatotoxicity. The NOAEL for males was 300 mg/kg bwt/day, but no NOA EL was obtained for females. In the mouse, the NOAEL for LCCPs was 7500 mg/kg bwt/day.OECD SIDS ALKANES, C 18

- 30 , CHLORO

26 Table 10: Repeat

- Dose Toxicity SUBSTANCE SPECIES EXPOSURE VALUE REL. REFERENCE C20

- 30 (liquid)
C22

- 26; 43% Cl rat 13 weeks,
gavage NOAEL: male 900 mg/kg/day; f emale could not be established LOAEL: male 3750 mg/kg/day; female 100 mg/kg/day 1 IRDC (1984b)

C 23 (average), 43% Cl rat 13 weeks,
gavage NOAEL: male > 3750 mg/kg/day (top dose); female could not be established LOAEL: female 235 mg/kg/day 2 NTP 198 6/ Bucher 1987

C 23 (average), 43% Cl rat 103 week
gavage LOAEL (mg/kg/day): male 1875 female 100 2 NTP 1986/ Bucher 1987

C 23 (average), 43% Cl mouse 13 weeks,
gavage NOAEL 7500 mg/kig/day (top dose) 2 NTP 1986/ Bucher 1987 C 23 (average), 43% Cl mou se 103 week
gavage NOAEL (mg/kg/day): male > 5000 (top dose) female > 5000 (top dose) 2 NTP 1986/ Bucher 1987

C22

- 26; 43% Cl rat 14 days,
gavage NOAEL > 3000 mg/kg/day (top dose) 1 IRDC (1981b)

C20

- 30 (solid)
C22

- 28; 70% Cl rat 13 weeks, oral feed NOAEL 900 mg/kg bw; LOAEL 3750 mg/kg/bw 1 IRDC (1984a)

C22

- 28; 70% Cl rat 14 days, oral feed NOAEL > 1715 mg/kg bw (top dose) 1 IRDC (1981a)

C22

- 28 ; 70% Cl rat 5 days,
gavage NOAEL > 5000 mg/kg bw (top dose) 2 IRDC (1982d)

In the NTP (1986) rat chr onic study, g roups of 50 male or 50 female F344 rats were given a C 23 , 43% Cl LCCP product dissolved in corn oil by gavage at doses of 0, 1875 and 3750 mg/kg bwt/day (males) or 0, 100, 300 or 900 mg/kg bwt/day (females), 5 days/week for 103 weeks. In addit ion, groups of 20 male and 20 female received the same doses for either 6 or 12 months in order to monitor any increase in organ weights and any changes in the levels of serum hepatic enzymes and haematological parameters. Increased liver weights were seen in both male and female rats, the effect being seen after 6 months dosing in female rats and after 12 months dosing in male rats. The effects were accompanied by a slight elevation in several serum enzyme levels and, in females only, variations in haemato logical parameters. The primary pathological lesion reported was a diffuse lymphohistiocytic inflammation of the liver and the pancreatic and mesenteric lymph nodes. No NOAEL for non

- neoplastic effects was observed in this study. The LOAEL for effects in t he liver was 1875 mg/kg bwt/day in male rats and 100 mg/kg bwt/day in female rats.

In the NTP (1986) mouse chronic study, g roups of 50 male or 50 female B6C3F1 mice were given a C 23 , 43%Cl LCCP product dissolved in corn oil by gavage at doses of 0, 2500 and 5000 mg/kg bwt/day, 5 days/week for 103 weeks. Treatment had no effect on survival and there were no clinical signs of toxicity or increases of non

- neoplastic lesions. Reduced weight gain was seen in some treated groups but the effect was not dose

- depe ndant. The NOAEL for both male and female mice was 5000 mg/kg bwt/day.OECD SIDS ALKANES, C 18

- 30 , CHLORO

27 There is no valid repeat

- dose toxicity study on a C 18

- 20 liquid grade LCCP, though repeat dose toxicity studies on the longer chain length compounds as well as on MCCPs (C14

- 17) are av ailable to provid e a source of read

- across data. In a recent and well

- conducted rat 90

- day dietary study of MCCPs (CXR, 2005 ), no effects were observed at 23 mg/kg/day and changes were seen in the kidneys at 222 mg/kg/day (increased weight, ‘chronic nephr itis’ and tubular pigmentation). Mechanistic studies indicated some deposition of α 2u

- globulin in proximal convoluted tubules of male rats only at higher dose levels. An increase in kidney weight of 9

- 13% was observed at the top dose of 222 mg.kg

- 1 .day

- 1 i n the CXR study and of 18% at the top dose of 625 mg.kg

- 1 .day

- 1 in another study (reference?). The increase above controls in the incidence and severity of what has been misleadingly termed ‘chronic nephritis’ (‘a mixed population of interstitial inflammat ory cells, tubular regeneration and minimal degenerative changes in the tubular epithelium occurring alone or in combination’) was seen in treated males at 10 mg.kg

- 1 .day

- 1 and above. At 10 mg.kg

- 1 .day

- 1 the severity of these changes was graded as ‘trace’, and even at the highest exposure level, 625 mg.kg

1 .day

- 1 , was only ‘mild’. Furthermore, a significant increase above controls in the incidence of this lesion (10/15 vs

. 1/15) was only seen at the top dose of 625 mg.kg

- 1 .day

- 1 with 3/15 and 4/15 animals a ffected at 10 and 100 mg.kg

- 1 .day

- 1 respectively. It is therefore concluded that, although kidney changes were observed from 10 mg.kg

- 1 .day

- 1 , a lesion considered to be of toxicological significance only occurred at the top dose of 625 mg.kg

- 1 .day

- 1

. Tub ular pigmentation was also seen in females at the top dose of 625 mg.kg

- 1 .day

- 1

.

Studies in Humans
No human experience following repeated exposure to LCCPs and repeated dose toxicity studies in humans on LCCPs have been reported.

Conclusion

There are vali d 90

- day repeat dose toxicity studies in the rat on a C 23 , 43%Cl LCCP, a C 22

- 26 , 43 % Cl LCCP (both liquid grades) and a C 22

- 28 , 70% Cl LCCP (a solid grade). There are also a valid 90

- day repeat dose toxicity studies in the mouse and valid 2

- year repeat do se studies in both the rat and the mouse on the C 23 (average), 43%Cl LCCP.

The principal target organ in both the 90

- day and the 2

- year studies was the liver, with some wider involvement of the lymphatic system in male rats and the haematological system i n female rats. The female rat was the most sensitive sex and species. The overall LOAEL for LCCPs in the 90

- day and 2

- year studies in the rat was 900 mg/kg bwt/day in males and 100 mg/kg bwt/day in females, based on hepatotoxicity. The NOAEL for males in t he 90

- day study was 300 mg/kg bwt/day, but no NOAEL was obtained for females. In the mouse, the overall NOAEL for LCCPs was 5000 mg/kg bwt/day based on the results of the 2

- year study.

Additionally, a NOAEL of 23 mg.kg

- 1 .day

- 1 is identified for repeated do se toxicity for MCCPs based upon effects seen in rat kidney (increased weight at the next dose level of 222 mg.kg

- 1 .day

- 1 and ‘chronic nephritis’ and tubular pigmentation at 625 mg.kg

- 1 .day

- 1 ). It is noted that at 222 mg.kg

1 .day

- 1 there were also slight d ecreases in plasma triglycerides and cholesterol levels. Th ese results may be considered in combination with the C 20

- 30 LCCPs as read

- across data for the C 18

- 20 LCCPs.OECD SIDS ALKANES, C 18

- 30 , CHLORO

28 3.1.6 Mutagenicity

Studies in Animals

In vitro Studies
Valid studies of liquid grade LCCP pr oducts have been shown to be negative in the Ames test, using the Salmonella strains shown below, both with and without metabolic activation.

Table 11: In Vitro Bacterial Cell Genetic Toxicity SUBSTANCE TYPE RESULT REL. REFERENCE C 18

- 20 (liquid)
C18

- 2 0; 40% Cl Ames

- Salmonella strains TA98, TA100, TA1535, TA1537, TA1538 Negative 2 Hoechst AG (year unknown) C 20

- 30 (liquid) C23 (av era g e ) 43% Cl Ames

- Salmonella strains TA98, TA100, TA1535, TA1537 Negative 1 Zeiger (1987).

C22

- 26; 42% Cl Ames

- Salm onella strains TA98, TA100, TA1535, TA1538 Negative 1 ICI (1981).

On the other hand, the C 23 (average) 43% Cl LCCP product was shown to cause chromosomal aberrations in Chinese hamster ovary (CHO) cells at a concentration of 5000 μ g/ml with metabolic activation. It also caused sister chromatid exchanges in CHO cells at concentrations ranging from 5.0 to 5000 ug/ml, both with and without metabolic activation.OECD SIDS ALKANES, C 18

- 30 , CHLORO

29 Table 12: In Vi tro Mammalian Cell Genetic Toxicity SUBSTANCE TYPE CON C. RESULTS REL. REFERENCE C23 (average); 43% Cl Chromosome aberration test

– Chinese Hamster Ovary (CHO) cells 1250 to 5000 ug/plate Increased chromosomal aberrations were seen following exposure to 5000 ug/plate only 1 Anderson (1990).

5, 500, 1700 and 5000 ug/plate Increased SCEs were observed at all concentrations tested. 1 Anderson (1990).

In vivo Studies

In

- vivo , both a C 22

- 26 , 43%Cl and a C 22

- 28 , 70%Cl LCCP product showed no evidence of chromosome aberrations in rat bone marrow cells (Fischer 344) following the administration of either product by gavage at doses of 500, 1500 or 5000 mg/kg bwt/day for 5 days.

Table 13: In Vivo Genetic Toxicity SUBSTANCE SPECIES EXPOSURE RESULTS REL. REFERENCE C20

- 30 (liquid)
C22

- 26; 43% Cl rat gavage, 5 da ys negative 1 IRDC (1983a). C20

- 30 (solid)
C22

- 28; 70% Cl rat gavage, 5 days negative 1 IRDC (1983e).

Studies in Humans
There are no reports of mutagenicity studies on LCCPs in humans.

Conclusion
In summary, LCCPs, like other CPs, do not induce mut ations in bacteria. There is some evidence of weak clastogenic potential in

- vitro in mammalian cells, but this is not seen in

- vivo in rat bone marrow cells. Taking all of the data on LCCPs into account and considering what is known about shorter chain CPs, it is concluded that LCCPs, as a group, are without significant mutagenic potential.

3.1.7 Carcinogenicity

In vitro Studies
There are no reports of relevant in

- vitro carcinogenicity studies on LCCPs in humans.

In vivo Studies in Animals

Inhalation
No carcinoge nicity studies are reported in which LCCPs have been administered by inhalation.

Dermal
No carcinogenicity studies are reported in which LCCPs have been administered by the dermal
route.OECD SIDS ALKANES, C 18

- 30 , CHLORO

30 Oral
Groups of 50 male or 50 female F344 rats were given a LCCP produ ct with an average C 23 (average) 43% Cl dissolved in corn oil by gavage at doses of 0, 1875 and 3750 mg/kg bwt/day (males) or 0, 100, 300 or 900 mg/kg bwt/day (females), 5 days/week for 103 weeks. The incidence of tumours in males was not affected by LCCP treatment. However, a dose

- related increased incidence in adrenal gland medullary phaeochromocytoma was seen in females in the LCCP treated groups (1/50, 4/50, 6/50 and 7/50 in the control, 100, 300 or 900 mg/kg/day, respectively). All the tumours, except for one at 100 mg/kg/day, were benign. The response in the high dose group being statistically significantly different from control values. Also, an increased incidence of endometrial stromal polyps of the uterus was reported, but the effect was not stat istically significant. The NTP report concludes that there was no evidence of carcinogenicity in male rats and equivocal evidence of carcinogenicity in female rats (NTP, 1986).

Groups of 50 male or 50 female B6C3F1 mice were given a LCCP product which had an average C 23 , 43% Cl composition dissolved in corn oil by gavage at doses of 0, 2500 and 5000 mg/kg bwt/day, 5 days/week for 103 weeks. In males there was a dose

- related increased incidence of malignant lymphomas (6/50 (12%), 12/50 (24%) and 16/50 (32%) in the control, 2500 and 5000 mg/kg/day groups, respectively). The historical incidence of this type of tumour in corn

- oil vehicle control male B6C3F 1 mice is 22%, similar to that observed at the lower dose level of 2500 mg/kg/day, so only the increased i ncidence at 5000 mg/kg/day can be considered to be treatment

related. Slight increases in the incidence of liver tumours and of follicular cell tumours of the thyroid gland were also observed, but the increased incidences were not statistically significant and were within the range of historical controls for the laboratory. The number of female deaths after week 65 was unusually high, probably the result of a Klebsiella oxytoca infection, which likely reduced the power of the study to detect a carcinogenic effect. In females there was a marginal increase in the incidence of hepatocellular carcinomas (1/50, 1/49 and 6/50 in the control, 2,500 and 5,000 mg/kg/day groups, respectively) and of adenomas and carcinomas combined (4/50, 3/49 and 10/50). The historic al incidence of hepatocellular carcinomas in corn

- oil vehicle control females was about half that observed in the high dose group. The NTP report concludes that there was clear evidence of carcinogenicity in male mice and equivocal evidence of carcinogenic ity in female mice (NTP, 1986; Bucher, 1987).

Studies in Humans
No epidemiological studies are reported in which populations have been exposed to LCCPs.

Conclusion
There are valid studies on the carcinogenic effects of a C 23 (average), 43% Cl LCCP in rats and mice. An increased incidence of malignant lymphoma in male mice reported at the highest dose tested, 5000 mg/kg/day, provid ed evidence that LCCPs are carcinogenic. Marginal increases in the incidence of adrenal medullary phaeochromocytomas observed in female rats from 100 mg/kg/day and in hepatocellular carcinomas in female mice at 5000 mg/kg/day were not considered to represent convincing evidence of carcinogenicity.

Overall, there is evidence that C 23 LCCPs are carcinogenic

, but only exposure level s that are so high (in excess of 2500 mg/kg/day) that the relevance of this property to a human health hazard assessment is doubtful.OECD SIDS ALKANES, C 18

- 30 , CHLORO

31 There are no valid studies on the carcinogenic effects of a C 18

- 20 liquid grade LCCP or a C >20 solid grade LCCP.

3.1.8 To xicity for Reproduction

Studies in Animals
Effects on Fertility
There are no specific studies of LCCPs on reproductive capability. No changes in the weight or macroscopic and microscopic appearance of the reproductive organs were reported in the repeated dose toxicity studies, available for the LCCP products tested.

Potential concern for reproductive pa rameters associated with MCCPs could conservatively be considered relevant to the C18

- C20 LCCP product. In a 1

- generation reproductive effects study of M CCPs in rats, an effect related to Vitamin K deficiency was noted in the pups. Studies in MCCPs have shown internal haemorrhaging in newborn rats, leading to death in some cases (UK Environment Agency, 2008). This effect is most likely due to a substantia l reduction in blood levels of Vitamin K in dams fed MCCPs. This reduction has been investigated with studies revealing very low Vitamin K levels in the milk and, consequently, low Vitamin K levels in the offspring (Elcombe et al 2004). Additional follow

- u p testing to more fully assess the impact of MCCPs on Vitamin K is being conducted and results should be available within the next year. Developmental Toxicity
Groups of 25 pregnant female CD rats were given a C 22

- 26, 43%Cl LCCP product at doses of 0, 500

, 2000 and 5000 mg/kg bwt/day from days 6 to 19 of gestation. The dams were terminated and all foetuses were recovered for examination on day 20. In the dams, there was no evidence of maternal toxicity. The developmental end points studied were the weight of the uterus, the number and location of viable foetuses, the number of early and late resorptions, the number of total implantations and corpora lutea and the incidence of foetal malformations. No signs of developmental toxicity were noted. The NOEL for both maternal and foetal toxicity in this study was 5 000 mg/kg bwt/day. (IRDC, 1983b ).

Groups of 25 pregnant female CD rats were given a C 22

- 28, 70 %Cl LCCP product at doses of 0, 500, 2000 and 5000 mg/kg bwt/day from days 6 to 19 of gestation. The dams w ere terminated and all foetuses were recovered for examination on day 20. In the dams, there was no evidence of maternal toxicity. The developmental end points studied were the weight of the uterus, the number and location of viable foetuses, the number of early and late resorptions, the number of total implantations and corpora lutea and the incidence of foetal malformations. No signs of developmental toxicity were noted. The NOEL for both maternal and foetal toxicity in this study was 5000 mg/kg bwt/day. (IRDC, 1984c).

Groups of 16 pregnant female Dutch Belted rabbits were given a C 22

- 26, 43%Cl LCCP product at doses of 0, 500, 2000 and 5000 mg/kg bwt/day from days 6 to 27 of gestation. The dams were terminated and all foetuses were recovered for examinati on on day 28. In the dams, there was no evidence of maternal toxicity. The developmental end points studied were the weight of the uterus, the number and location of viable foetuses, the number of early and late resorptions, the number of total implantatio ns and corpora lutea and the incidence of foetal malformations. In the dams receiving 5000 mg/kg bwt/day, there was a slight increase in mean implantation loss and a slight decrease in the mean number of viable foetuses. However, these effects were not sta tistically significant. In the foetuses, no treatment

- related effects were observed, although the number of foetuses examined in the high

- dose group was small. No teratogenic or developmental effects wereOECD SIDS ALKANES, C 18

- 30 , CHLORO

32 observed. The NOEL for maternal toxicity in this st udy was 5000 mg/kg bwt/day. The NOEL for foetotoxicity in this study was 2000 mg/kg bwt/day (IRDC 198 2a ).

Groups of 16 pregnant female Dutch Belted rabbits were given a C 22

- 28, 70%Cl LCCP product at doses of 0, 100, 300 and 1000 mg/kg bwt/day from days 6 to 27 of gestation. The dams were terminated and all foetuses were recovered for examination on day 28. In the dams, there was an incidence of lung congestion that was not dose

- related. There was no other evidence of maternal toxicity. The developmental e nd points studied were the weight of the uterus, the number and location of viable foetuses, the number of early and late resorptions, the number of total implantations and corpora lutea and the incidence of foetal malformations. No adverse toxic or develo pmental effects on the foetuses were observed. The NOEL for both maternal and foetal toxicity in this study was 1000 mg/kg bwt/day (IRDC 1983c).OECD SIDS ALKANES, C 18

- 30 , CHLORO

33 Table 14: Developmental Toxicity SUBSTANCE SPECIES EXPOSURE DOSE VALUE REL. REF. C20

- 30 (liquid)
C22

- 26; 4 3% Cl R at gavage; daily on gestation days 5

- 19 0, 3000, 5000 mg/kg/day NOAEL Maternal Toxicity = 3000 mg/kg bw NOAEL Teratogenicity > 5000 mg/kg bw 2 IRDC (1981d).

C22

- 26; 43% Cl R at gavage; daily on gestation days 6

- 19 0, 500, 2000, 5000 mg/kg body weigh t NOAEL Maternal Toxicity > 5000 mg/kg bw NOAEL Teratogenicity > 5000 mg/kg bw 1 IRDC (1983b).

C22

- 26; 43% Cl rabbit gavage; daily on gestation days 6

- 27 0, 500, 1000, 2000, 3000, 5000 mg/kg/day NOAEL Maternal Toxicity = 2000 mg/kg bw NOAEL Teratogenicit y > 5000 mg/kg bw 2 IRDC (1981c).

C22

- 26; 43% Cl rabbit gavage; daily on gestation days 6

- 27 0, 500, 2000, 5000 mg/kg/day NOAEL Maternal Toxicity = 2000 mg/kg bw NOAEL Teratogenicity = 2000 mg/kg bw 1 IRDC (1982a).

C20

- 30 (solid)
C22

- 30; 70% Cl R at ga vage; daily on gestation days 6

- 19 0, 1000, 2000, 5000 mg/kg/day NOAEL Maternal Toxicity = 2000 mg/kg bw NOAEL Teratogenicity > 5000 mg/kg bw 2 IRDC (1983d).

C22

- 30; 70% Cl R at gavage; daily on gestation days 6

- 19 0, 500, 2000, 5000 mg/kg/day NOAEL Mater nal Toxicity > 5000 mg/kg bw NOAEL Teratogenicity > 5000 mg/kg bw 1 IRDC (1984c).

C22

- 30; 70% Cl rabbit gavage; daily on gestation days 6

- 27 0, 100, 300, 1000 mg/kg body wt./ day NOAEL Maternal Toxicity < 100 mg/kg bw NOAEL Teratogenicity > 1000 mg/kg bw 1 IRDC (1983c).

C22

- 30; 70% Cl rabbit gavage; daily on gestation days 6

- 27 0, 2000, 3750, 5000 mg/kg/day NOAEL Maternal Toxicity < 2000 mg/kg bw 2 IRDC (1982b).

C22

- 30; 70% Cl rabbit gavage; daily on gestation days 6

- 27 50, 200, 1000 mg/kg/day NOAEL Maternal Toxicity = 200 mg/kg bw NOAEL Teratogenicity > 1000 mg/kg bw 2 IRDC (1982c).

Studies in Humans
Effects on Fertility
There are no relevant fertility studies on LCCPs in humans.
Developmental Toxicity
There are no relevant developmental toxici ty studies on LCCPs in humans.

Conclusion
Effects on Fertility
There are no studies of LCCPs on reproductive capability. No changes in the weight or macroscopic and microscopic appearance of the reproductive organs were reported in the repeated dose toxic ity studies, available for the LCCP products tested.

Developmental ToxicityOECD SIDS ALKANES, C 18

- 30 , CHLORO

34 There are valid developmental toxicity studies on both solid and liquid grade LCCPs with a carbon chain length 20

- 30 . There is no evidence that these grades of LCCP cause develo pmental effects in either rats or rabbits. There was some evidence that these grades of LCCP might impact on implantation and foetal survival in the rabbit, although the effect was not statistically significant at the highest dose level studied, 5000 mg/kg bwt/day.
There is no valid developmental toxicity study on a C 18

- 20 liquid grade LCCP. However, given the results of the studies on the C >20 LCCPs and the fact that MCCPs have shown no adverse effects in developmental toxicity studies, it is concluded th at the C 18

- 20 liquid grade LCCP are also likely to be devoid of developmental toxic effects.

3.2 Initial Assessment for Human Health

Toxicokinetics, metabolism and distribution

90

- day studies, in which radio

- labelled LCCPs were administered orally to rats, sho wed that they were poorly absorbed from the GI tract, >80% of the administered radio

- activity being excreted in the faeces within seven days. (IRDC 1984a; IRC 1984b.)
There have been no studies on absorption through the skin. It is known that both SCCPs a nd MCCPs are absorbed via this route to only a very small extent. It is not anticipated that LCCPs would behave any differently. Similarly, there are no studies on the absorption of LCCPs through the respiratory tract, either as vapour, aerosol or dust. It is not anticipated that LCCPs would be absorbed to any significant extent via this route.
Acute toxicity
There is adequate data to assess the acute toxicity of LCCPs. LCCP grades with carbon chain length 20

- 30 (both solid and liquid) are of very low acute toxicity, having oral LD 50 values in excess of 2.0 mg/kg bwt in the rat and other species. It is known that MCCPs also are of very low acute toxicity. (UK Environment Agency, 2007). As such it is likely that C 18

- 20 liquid grade LCCPs are of very low
acute toxicity, having oral LD 50 values in excess of 2.0 mg/kg bwt in the rat.
There are no data on the acute toxicity of LCCPs following dermal administration. However, as it is anticipated that they would not be absorbed to any significant extent via this rou te, it is considered unnecessary to conduct such tests. Similarly, there are no data on the acute toxicity of LCCPs following inhalation. However, as it is anticipated that they would not be absorbed to any significant extent via this route, it is consider ed unnecessary to conduct such tests.

Irritation
There is adequate data to assess the irritant potential of LCCPs. LCCPs have been shown to be, at most, only slightly irritant to the skin and eyes in experimental animals. They would not be anticipated to b e irritating to the respiratory tract.

Sensitisation

There are no valid available data to indicate that LCCPs cause skin sensitisation.

Repeat

- dose toxicity

There are valid 90

- day repeat dose toxicity studies in the rat on a C 23 , 43%Cl LCCP, a C 22

- 26 , 43 % Cl LCCP (both liquid grades) and a C 22

- 28 , 70% Cl LCCP (a solid grade). There are also a valid 90

- day repeat dose toxicity studies in the mouse and valid 2

- year repeat dose studies in both the rat and the mouse on the C 23 , 43%Cl LCCP.OECD SIDS ALKANES, C 18

- 30 , CHLORO

35 The principal tar get organ in both the 90

- day and the 2

- year studies was the liver, with some wider involvement of the lymphatic system in male rats and the haematological system in female rats. The female rat was the most sensitive sex and species. The overall LOAEL for L CCPs in the 90

- day and 2

- year studies in the rat was 900 mg/kg bwt/day in males and 100 mg/kg bwt/day in females, based on hepatotoxicity. The NOAEL for males in the 90

- day study was 300 mg/kg bwt/day, but no NOAEL was obtained for females. In the mouse, t he overall NOAEL for LCCPs was 5000 mg/kg bwt/day based on the results of the 2

- year study.

There is no valid repeat

- dose toxicity study on a C 18

- 20 liquid grade LCCP , though available data on M CCPs , C14

- 17, with a NOAEL of 23 mg/kg/day, to use for read a cross purposes.

Mutagenicity

There is adequate data to assess the mutagenic potential of LCCPs. LCCPs, like other CPs, do not induce mutations in bacteria. There is some evidence of weak clastogenic potential in

- vitro in mammalian cells, but this is not seen in

- vivo in rat bone marrow cells. Taking all of the data on LCCPs into account and considering what is known about shorter chain CPs, it is concluded that LCCPs, as a group, are without significant mutagenic potential.

Carcinogenicity

There are valid studies on the carcinogenic effects of a C 23 , 43%Cl LCCP in rats and mice. Overall, whilst there is some evidence from animal studies that exposure to C 23 , 43%Cl LCCP may lead to tumours, the evidence is, at best, weak.

There are no valid studies on the carcinogenic effects of a C 18

- 20 liquid grade LCCP or a C >20 solid grade LCCP. However, given the results on the studies in rats and mice on the C >20 liquid grade LCCP and the fact that CPs, in general, are not genotoxic, it would seem inappropriate to conduct further carcinogenicity studies in animals on these grades.

It is concluded that LCCPs do not present a carcinogenic hazard for humans.

Toxicity for Reproduction
Effects on Fertility
There are no studies of LCCPs on reproductive capability. A 1

- generation reproductive effects study of MCCPs in rats is available. This study demonstrated a potential effect from lactation which appears to be most likely due to a substantial reduction in blood levels of Vitamin K in dams fed MCCPs.

Developmental To xicity
There are valid developmental toxicity studies on both solid and liquid grade LCCPs with a carbon chain length 20

- 30 . There is no evidence that these grades of LCCP cause developmental effects in either rats or rabbits. There was some evidence that these grades of LCCP might impact on implantation and foetal survival in the rabbit, although the effect was not statistically significant at the highest dose level studied, 5000 mg/kg bwt/day.
There is no valid developmental toxicity study on a C 18

- 20 liq uid grade LCCP. However, given the results of the studies on the C >20 LCCPs and the fact that MCCPs have shown no adverse effectsOECD SIDS ALKANES, C 18

- 30 , CHLORO

36 in developmental toxicity studies, it is concluded that the C 18

- 20 liquid grade LCCP are also likely to be devoid of developm ental toxic effects.



### 4 HAZARDS TO THE ENVIR ONMENT

4.1 Aquatic Effects

Valid a quatic toxicity data are available for fish and invertebrates . There are no valid data available for algae. While in general, aquatic toxicity of chlorinated paraffins appears to be inversely related to the carbon chain length and degree of chlorination, the most sensitive species for short

chain and mid

- chain chlorinated paraffins was identified as Daphnia magna. Therefore it can be predicted that if LCCPs exhibit effects below their limit of water solubility, these will be most apparent in Daphnia magna. Measured algal data for SCCPs and MCCPs are presented. The overall trends observed in measured toxicity for chlorinated paraffins and the algal data presented suggest that filling th is data gap is not critical for the environmental hazard assessment

. Quantitative r ead across is not presented for the algal endpoint , since the SCCPs result was extrapolated and neither a dose

- response nor an EC 50 could be derived from the MCCP data due t o absence of effects

.
Aquatic toxicity testing is problematic due to the very low water solubility of LCCPs. In addition, owing partly to the variety of methods used to prepare test solutions there is a lack of certainty that saturated test solutions di d not contain undissolved test substance in many instances. This, and the fact that any effects observed were near the limit of water solubility, complicates interpretation of test results.

Acute Toxicity Test Results

Acute toxicity data are available on several different species of fish and also on invertebrates ( Daphnia magna ). No acute toxicity effects were observed in fish for either liquid or solid LCCPs, with the lowest tested concentration being 300 mg/L. Table 15 presents the results of the ac ute fish toxicity studies on LCCPs.

Johnson and Finley (1980) summarised the results of acute toxicity tests carried out by the Columbia National Fisheries Research Laboratory over the years 1965

- 1978. Few details of the test methods are available, and so it is not possible to validate these data. The 96

- hour LC 50 values reported for LCCPs with both rainbow trout ( Oncorhynchus mykiss ) and bluegill sunfish ( Lepomis macrochirus ) were >300 mg/l for a C 20

- 30 , 40

- 42% wt Cl product, >300 mg/l for a C >20 , 48

- 5 4% wt Cl product and >300 mg/l for a C 20

- 30 , 70% wt Cl product. The paper also reports similar results for a C 18

- 20 , 39% wt Cl product in rainbow trout and bluegill sunfish.

Lindén et al. (1979) studied the toxicity of a C 22

- 26 , 42% wt. Cl product over 96 hours with bleak ( Alburnus alburnus ) in brackish water. The tests were carried out under static conditions with no aeration (the dissolved oxygen level was measured at the end of the test and was considered to be acceptable if the concentration was ≥5 mg/l). The water used in the test had a salinity of 7%

, a temperature of 10°C and a pH of around 7.8. Six test concentrations and one control were used in the test, with groups of ten fish exposed at each concentr ation. The test substance was dissolved in acetone prior to addition to the test chamber; the concentration of acetone in the final solution was ≤0.5 mg/l. No monitoring of the actual concentration of the test substance was carried out during the test, and the 96h

- LC 50 was determined as >5,000 mg/l based on the nominal concentration added at the start of the test.OECD SIDS ALKANES, C 18

- 30 , CHLORO

37 Madeley and Birtley (1980) summarised the results of acute toxicity tests using a C 20

- 30 , 42% wt Cl product with rainbow trout ( Oncorhynchus mykiss ). A concentrated emulsion of the c hlorinated paraffin was prepared and dilutions of this emulsion were used in the test. No further information is available on the media preparation technique. A semi

- static test system was used, with the test solution being renewed every 24 hours. The te sts were carried out at a temperature of 15±1°C for 96 hours with 10 fish at each exposure concentration. The emulsion concentration was verified by measurement (using infrared spectrophotometry after solvent extraction of the chlorinated paraffin). Some loss of chlorinated paraffin from the test emulsions was seen, particularly at the higher concentrations tested, and so the results are based on the mean measured level found in the emulsions. No toxicity or unusual behaviour was seen at the highest conc entration tested (mean measured emulsion concentration 770 mg/l).

Table 15 : Acute Toxicity of LCCPs to Fish

Substance Species Exposure Value Rel. Reference
C18

- 20 (liquid)
C 18

- 20 ; 39% Cl Oncorhynchus mykiss / Salmo gairdneri 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finley (1980). C18

- 20; 49% Cl Leuciscus idus 48 hrs 48h Toxic Threshold >500 mg/L (nominal) 2 Hoechst AG (1976).

C18

- 20; 52% Cl Leuciscus idus 48 hrs 48h Toxic Threshold >500 mg/L (nominal) 2 Hoechst A G (1976).

C20

- 30 (liquid)

C22

- 26; 42% Cl Alburnus alburnus 96 hrs LC50 > 5000 mg/L (nominal) 2 Linden et al. (1979).

C20

- 30; 40% Cl Lepomis macrochirus 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finley (1980). C22

- 26 ; 48

- 50% Cl Lepomis macrochirus 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finley (1980). C22

- 26; 48

- 50% Oncorhynchus mykiss / Salmo gairdneri 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finley (1980) . C20

- 30; 40% Cl Oncorhynchus mykiss / Salmo gairdneri 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finley (1980). C20

- 30; 42% Cl Oncorhynchus mykiss / Salmo gairdneri 96 hrs Toxic Threshold > 770 mg/L (nominal) 2 Madeley & Birtl ey (1980).

C20

- 30 (solid)
C22

- 26; 70% Cl Lepomis macrochirus 96 hrs LC50 > 300 mg/L (nominal) 2 Johnson & Finley (1980). C22

- 26; 70 % Cl Oncorhynchus mykiss / Salmo gairdneri 96 hrs LC50 > 300 mg/L (nominal) 2 Howard et al. (1975). Johnson & Finle y (1980).

There are several acute studies in Daphnia magna ; including studies on a commercial LCCP C 18

- 20 , 52% wt Cl product and another on a C >20 43% wt Cl LCCP

. Table 16 presents the results of the acute invertebrate studies for LCCPs.

The stud ies by Frank et al. (1993 , 1994 ) on the C 18

- 20 , 52% wt Cl product w ere conducted using dilutions of the water soluble fraction of the chlorinated paraffin. Stock solutions of the chlorinatedOECD SIDS ALKANES, C 18

- 30 , CHLORO

38 paraffin were made up in water to give nominal concentrations of eithe r 100 mg/l or 10 g/l. B oth solutions were filtered w ith glass a nd membrane filters to remove undissolved test material (microscopic and spectroscopic investigation of the filtered solutions gave no indication of the presence of droplets) to give the respe ctive water soluble fractions. The concentration of the chlorinated paraffin in the water soluble fractions was determined by AOX (adsorbable organic halogen) analysis. The detection limit of the method used was around 10 μg Cl/l, which is equivalent to around 20 μg/l of the chlorinated paraffin. In the first experiment, t his analysis showed that the concentration of chlorinated paraffin present in the water soluble fraction was around 462

- 519 μg/l for the 10 g/l nominal solution but was not detectable in the 100 mg/l solution (i.e. <20 μg/l). The 10 g/l nominal stock solution an EC 0 of 360 μg/l and an EC 15 of 500 μg/l was determined (maximum mortality seen was 15%). These same results (recalculated as EC 0 of 357 μg/l and EC 15 as 400 μg/l for the 10 g/l nominal stock solution), along with the results of another acute test using the same methodology are reported in Frank and Steinhäuser (1994). No effects were seen in the second acute toxicity tests with the 100 mg/l nominal stock solution (EC 0 ≥26 μg/l) or the 10 g/l nominal stock solution (EC 0 ≥877 μg/l). The authors noted that the effects seen in the acute tests showed poor reproducibility, probably because effects were seen only around the solubility limit in the test system used. However, the authors thought that the possibility of undis s olved droplets affecting the results could be ruled out as floating Daphnia were only sporadically observed in the test. Nevertheless, the results of th ese test s should be treated with caution, as the effects were ma inly seen in the saturated solutions only (UK EA 200 9 )

.
The study by Thompson (2005) tested w ater accommodated fraction s at initial loadings of 0.21, 1.0 and 5.1 mg/l. While some question has been raised about the sufficiency of the equilibrium time (UK EA 2009), no effects were observed over a 48 hour period.

Table 16 : Acute Toxicity of LCCPs to Aquatic Invertebrates

Substance Species Exposure Value Rel. Reference
C 18

- 20 (liquid)
C18

- 20; 52% Cl Daphnia magna 48 hrs EC0 = 36 0 μ g/L (measured) EC15 = 4 00

- 5 00 μ g/L (measured) (15% max. mortality) 2 Frank (1993). UK Environment Agency (2009 ).

C18

- 20; 52% Cl Daphnia magna 48 hrs EC0 = >26

- >877 μg/L (measured) (no effects observed) 2 Frank & Steinhauser (1994). UK Environment Agency (200 9 ).

C 20

- 30 (l iquid)
C20

- 30 ; 43% Cl Daphnia magna 48 hrs No adverse effects seen over 48 hours. (5.1 mg/l WAF) 2 Thomp s on (2005)

Toxicity to Aquatic Plants
Craigie and Hutzinger (1975) determined the toxicity of a C 20

- 30 , 50% wt Cl product to three species of marine algae ( Dunaliella tertiolecta, Olisthodiscus sp. and Thalassiosira fluviatilis ). The tests were carried out for 6 days at 20°C. The chlorinated paraffin was dissolved in acetone and an appropriate volume of this solution was added to the flask and evapor ated to dryness under a jet of air. Natural sea water (30 ml) was then added to the flasks and the flasks were stoppered with a cotton wool bung and autoclaved. The nominal chlorinated paraffin concentrations tested were 1 mg/l and 100 mg/l but no measur ements were carried out to verify the actual exposureOECD SIDS ALKANES, C 18

- 30 , CHLORO

39 concentration. The test was started by adding a 1 ml inoculum of 3 to 4 day old algal culture to the flask and each flask was shaken by hand twice daily. Each concentration was tested in duplicate. T he algal biomass was determined by turbidity measurements after 6 days exposure. No effects on biomass was seen in any of the exposed populations (the turbidity of the solutions was within 96

- 105% of the control values.

The validity of this test is highl y questionable as the method of administration of the test substance may not have been appropriate. It appears that an acetone solution of the substance was added directly to the test vessel and evaporated to dryness before the test water was added, and t hen the vessel was autoclaved (the temperature was not stated). As this substance is likely to be highly adsorptive onto the glass vessel used, and twice daily shaking of the vessel was the only method used to effect mixing, it is highly uncertain that al l the chlorinated paraffin added would be in solution, or even in suspension and it is possible that most of it remained adsorbed onto the test vessel. As no monitoring was carried out during the test it is not possible to determine if any substance was l ost during the autoclaving procedure (UK EA 200 9 ).

For chlorinated paraffins as a whole, toxicity seems to decrease as chain length and degree of chlorination increase. Measured algal data are available for the homologues SCCPs and MCCPs, which are presen ted below. These data suggest that LCCPs would not be expected to exert effects on freshwater algae below their limit of water solubility.

Predictions of algal toxicity have not been presented as the model used does not perform well for these kinds of s ubstances.

SCCP Algal Tox i city

Several valid studies on freshwater and marine algae are available for SCCPs. 96

- hour EC50s range from 0.043 to 3.7 mg/l

, with the marine alga Skeletonemacostatum appearing to be more sensitive to short chain length paraff ins than the freshwater alga Selenastrum capricornutum ( 96

- hour EC50 = 3.7 mg/l based on cell density by particle count).

It shou ld be noted that the EC50 value given for Selenastrum exceeded the highest mean measured concentrations of the test substanc e; it is an extrapolated value . Further, the toxic effects seen with the marine alga were transient, with no effects being seen at any concentration after 7 days
exposure.

MCCP Algal Toxicity

The toxicity of a C 14

- 17 , 52% wt. Cl paraffin to the green alg a Selenastrum capricornutum was determined in a valid study using OECD method 201. Overall, very little effect on algal growth was observed in the test. The maximum inhibition in the growth rate seen was 3%, and the maximum inhibition of biomass was 18%. N o clear dose

- response curve was determined. The NOEC from the test is around 0.1 mg/l (nominal), but it should be noted that no statistically significant effects were seen at some higher concentrations. The low levels of inhibition seen mean that it is not possible to derive an EC 50 from the test.

Toxicity to Microorganisms
There are four studies in microorganisms available, three of which were conducted according to OECD 209 TG. While all four studies are assigned a reliability code of 4 ( not assignable), their concurrent results suggest that LCCPs are of low toxicity to microogranisms (tests according to OECD 209 TG returned NOECs of 1000 mg/l or higher ).OECD SIDS ALKANES, C 18

- 30 , CHLORO

40 Chronic Toxicity Test Results

Chroni c aquatic data are available in fish and invertebrates for both liquid and solid LCCPs. Table 17 reports the results for chronic aquatic toxicity studies in fish and Table 18 reports the results for the chronic aquatic toxicity studies in invertebrates.

The difficulties already outlined in testing LCCPs make interpr etation of some of the results difficult. In addition, methods to prepare test solutions may result in the more soluble components present in the commercial LCCP being preferentially represented in the resultant solution. This should be borne in mind espec ially when considering the chronic aquatic toxicity dataset.

Chronic Fish Toxicity

Bengtsson et al. (1979) studied the toxicity of a C 18

- 26 , 49% wt Cl LCCP to bleak fish ( Alburnus alburnus ) as part of a bioaccumulation study. The tests were performed at 10°C using a semi

- static procedure in which the test solutions containing 125 μg/l of the substance were renewed every two to three days over the 14 day exposure period. The water used in the experiment was Baltic Sea water with a salinity of 7‰, and ace tone was present in all aquaria, including controls at a concentration of 0.1 ml/l. The fish used in the experiment had an average weight of 4.5 g and were not fed during the exposure period. Six groups of 15 fish were used for both the exposure and
contr ol solutions. No mortality or effect on behaviour was seen in fish exposed to the LCCP d uring the test.

The toxicity of two LCCPs to rainbow trout ( Oncorhynchus mykiss ) has been studied over 60 days in a GLP study (Madeley and Maddock, 1983a and 1983b). The substances tested were a C 22

- 26 , 43% wt. Cl LCCP and a C 20

- 30 , 70% wt Cl LCCP . Both products were mixed with

n

- pentacosane

- 13

- 14 C that had been chlorinated to a similar degree. Neither of the commercial products tested contained a stabiliser. A flow

- through system was used for each test and the concentrations of chlorinated paraffin were determined by both radioactivity measurements and parent compound analysis (using a TLC technique). The tests were carried out at 12±1°C. For the tests with the 43% wt Cl product the water quality parameters were: dissolved oxygen 9.3

- 11.4 mg/l; pH 7.4

- 8.55; hardness 42

- 71 mg/l as CaCO 3 . Similar ly for the tests with the 70% wt Cl product the water quality parameters were: dissolved oxygen 10.4

- 12.5 mg/l; pH 7.5

- 8.1; hardness 36

- 46 mg/l as CaCO 3 . The fish were fed a diet of proprietary trout food throughout the test at a rate of 2% of body weight/day. The major endpoint determined at the end of the studies was mortality. However, qualitative observations were also made on behaviour (the control fish were assumed to show "normal" behaviour) in terms of: a) swimming behaviour; b) general behaviour of individuals (e.g. intense activity, sluggishness, quiescence, position in test vessel); c) response to presence of food ; d) skin pigmentation.

In both tests, fish were introduced into the exposure vessels 1 week prior to addition of the test substance. At the start of the test, the chlorinated paraffin (as an acetone solution) was added to the in

- flowing water. The fl ow

- through system used had a 95% replacement time of around 7 hours, and so the actual exposure concentration would have reached the steady state level within a relatively short space of time. The fish used in the study weighed 1.4

- 3.2 g (for the experime nts with 43% wt Cl substances) and 0.53

- 2.77 g (for the experiments with the 70% wt Cl substance) at the start of the study and groups of 30 fish were used at each exposure concentration.OECD SIDS ALKANES, C 18

- 30 , CHLORO

41 Table 17 : Chronic Toxicity to Fish

Substance Species Exposure Val ue Rel. Reference
C20

- 30 (liquid)
C18

- 26; 49% Cl Alburnus alburnus 14 days NOEC > 0.125 mg/L (nominal) 2 Bengtsson et al. (1979).

C22

- 26; 43% Cl Oncorhynchus mykiss / Salmo gairdneri 60 days NOEC = 4 mg/L (measured) 2 Madeley & Maddock (198 3a).

C20

- 30 (solid)
C20

- 30 ; 70% Cl Oncorhynchus mykiss / Salmo gairdneri 60 days NOEC = 3.8 mg/L (measured) 2 Madeley & Maddock (1983 b ).

For the C 22

- 26 , 43% wt Cl substance (Madeley and Maddock, 1983a), two nominal exposure concentrations of 1. 0 and 3.2 mg/l were used. Acetone at a concentration of 500 ppm (0.5 ml/l) was also present in the test solutions and so acetone controls were also run in the test. The actual mean measured exposure concentrations during the test were 0.97 mg/l and 4.0 m g/l at the two exposure concentrations respectively. These values were based on 14 C

- measurements (parent compound analysis was in general agreement with these values). No fish died during the study. One fish was lost from the acetone control ( reported t o have escaped), and no significant effects were seen on behaviour of the exposed fish compared with controls. The NOEC from this study was therefore reported as 4.0 mg/l, the highest concentration tested. The test report gives details of the fish weight s and lengths at the end of the study. These were 9.46 g and 84.2 mm in the freshwater controls; 9.23 g and 81.2 mm in the acetone controls, 8.59 g and 81.5 mm in the 0.97 mg/l exposure group and 8.38 g (this is incorrectly given as 7.38 g in the original report) and 80.7 mm in the 4.0 mg/l exposure group. These weight data are not commented on in the report but have subsequently been analysed statistically to show that there was no significant (p=0.05) differences in mean fish weights between the exposed populations or the control or solvent control populations (Thompson, 2001). The mean length of the fish was similar in all exposed and control populations.

For the C 20

- 30 , 70% wt Cl substance (Madeley and Maddock, 1983b) three nominal exposure
concentra tions of 1.0 mg/l, 2.1 mg/l and 4.2 mg/l were used. Acetone at a concentration of 500 ppm (0.5 ml/l) for the two lower exposure concentrations or 1,000 ppm (1 ml/l) for the higher exposure concentration was also present in the test and so two acetone cont rols were run. The mean measured exposure concentrations by 14 C

- analysis were 0.84 mg/l, 1.9 mg/l and 3.8 mg/l in the three test solutions respectively (parent compound analysis gave similar values). No significant mortalities occurred as a result of the exposures. A small number of deaths or losses did occur in all exposure vessels, but this was not considered unusual in a 60 day study. Abnormal behaviour (a few individuals were slow to respond to the presence of food and showed a darkening of skin pig mentation) was observed in all populations, including controls. These symptoms became apparent on day 3 and had disappeared by day 7. A similar behaviour re

- occurred in the acetone control populations between days 12

- 16. Subsequently, all populations be haved normally except for isolated occurrences. In the early part of the study, the fish in the 3.8 mg/l group, and to a lesser extent the 1.9 mg/l group, found it difficult to locate their food due to the cloudy nature of the suspensions tested, however they later appeared to become acclimatised to the test conditions. It was concluded that no chemical

- related effects on the behaviour of the fish was seen in the study. Although not commented on in the test report, mean fish weights and lengths were also reported.OECD SIDS ALKANES, C 18

- 30 , CHLORO

42 These were 3.87 g and 59.2 mm in the freshwater controls, 4.14 g and 60.9 mm in the 500 ppm acetone controls, 3.70 g and 59.5 mm in the 1,000 ppm acetone controls, 4.74 g and 65.3 mm in the 0.84 mg/l exposure group, 5.05 g and 66.0 mm in the 1. 9 mg/l exposure group and 4.11 g and 62.4 mm in the 3.8 mg/l exposure group. Although it is not possible to analyse these data statistically, it is clear that no effects on growth were seen as a result of the chlorinated paraffin treatments in this
test. The NOEC from this study is therefore 3.8 mg/l.

Chronic Daphnia Toxicity

There are several 21

- day reproduction studies in Da phnia magna on liquid LCCPs. The most recent and best documented of these is the study by Sharpe and Penwell ( 2007) , which te ste d a 14 C

labelled, C 25 , 43% wt Cl chlorinated alkane , single chemical not a commercial LCCP, according to the OECD 211 method using a semi

- static test procedure. In this study, a stock solution of the test substance was prepared in dimethylformamide and al iquots of this were added to Elendt’s M4 medium for use in the test (the amount of dimethylformamide in the test solution was 0.1 ml/l). The test medium had a hardness of 234 mg/l as CaCO 3 . Test solutions were renewed every 48 hours during the test. The exposures were carried out using borosilicate glass beakers each containing 1 organism and 80 ml of test solution. A total of ten replicates per treatment group were carried out. The nominal concentrations tested were 2.0, 4.0, 8.0, 16, 32 and 64 μg/l an d a dilution water control and solvent control group were also run. The actual concentration of chlorinated paraffin present was determined in “fresh” and “spent” solution at days 0

- 2, 4

- 6, 10

- 12 and 18

- 20. The analytical method used was radiochemical an alysis (direct scintillation counting of the test solution). The measured concentrations in “fresh” solutions ranged from 85% to 105% of the nominal values and the measured concentrations in the “spent” solutions ranged from 50% to 84% of the nominal valu es. The mean m easured concentrations found in the six treatment groups were 1.6, 3.0, 5.4, 13, 27 and 55 μg/l respectively. It should be noted that this analytical method would not necessarily distinguish between truly dissolved chlorinated paraffin and non

- dissolved c hlorinated paraffin. The endpoints determined in the study were adult length, reproduction (number of live offspring produced per parent animal surviving to the end of the study) and adult mortality. No statistically significant differences (at the p=0. 05 level) were seen between the treatment groups and the control groups for either adult length or reproductio n, as such the NOEC = 55 μg/ L.OECD SIDS ALKANES, C 18

- 30 , CHLORO

43 Table 18 : Chronic Toxicity to Aquatic Invertebrates

Substance Species Exposure Value Rel. Reference
C18

- 20 (liquid)
C 18

- 20 , 52% wt. Cl Daphnia magna 21 days No statistically significant effects observed at 2 μg/L (NOEC) ( measured; based on re

- analysis by Thompson) 2 Hooftman and Henzen/ TNO 1993 Thompson 200 7

.

C 18

- 20 ; 52% wt. Cl Daphnia magna 21 days ~29

– 32 ug/l (NOEC) (measured) 2 Frank (1993); Frank and Steinhäuser (1994) C20

- 30 (liquid) C25; 43% Cl Daphnia magna 21 days NOEC = 55 ug/ L (measured) LOEC > 55 ug/L (measured) EC50 > 55 ug/L (measured) 1 Sharpe & Penwell (2007)

C22

- 26; 43% Cl Mytilus edulis 60 days NOEC: 2.18 mg/L (measured) LOEC: 2. 18 mg/L (measured) 2 Madeley & Thompson (1983b)

C20

- 30 (solid)

C20

- 30 ; 70% Cl Mytilus e dulis 60 days NOEC: 1.33 mg/L (measured) LOEC: 1.33 mg/L (measured) 2 Madeley & Thompson (1983a)

A 21

- day study of C18

- 20; 52

- 56% Cl in Daphnia magna was carried out by TNO ( Hooftman and Henzen 1993). The substance tested was a commercial product cont aining 1.5% epoxidised soybean oil. The test was carried out according to the OECD 202 methodology using a semi

- static test procedure (test solution renewal was carried out every 48

- 72 hours). The dilution water used was a synthetic medium (DSWL) prepare d by addition of various salts to ground water. The hardness of the medium was 214 mg/l as CaCO 3

. The study tested a saturated solution, a blank control (DSWL medium only) and a column control (DSWL medium pumped through a column containing unspiked chrom osorb 60/80 mesh). Four replicates (10 daphnids in 400 ml of test solution) were carried out for each treatment. The parent survival in both of the control groups was 97.5%. In the C 18

- 20 , 52% wt. Cl treatment group the parent survival was 92.5%. This was not statistically significantly different (at the p=0.05 level) from the control group s . Therefore it was concluded that no treatment

- related effects on parent morality were seen in the study. The reproduction rate (expressed as the cumulative numbe r of young per living female) in the study was 113.6 in the blank control and 127.3 in the column control. The response of the two controls was not statistically significantly different (at the p=0.05 level). The reproduction rate in the C 18

- 20 , 52%
wt. Cl treatment group was 100.8. This was 88.7% of the blank control response and 79.1% of the column control response. These responses were analysed statistically in TNO ( Hooftman and Henzen 1993) using the two

- tailed Dunnett

- test with a 95% significance l evel. No statistically significant differences were found between the C 18

- 20 , 52% wt. Cl treatment group and the blank control but it is not entirely clear from the report whether the reduction in the reproduction rate in the treatment group compared to t he column control was statistically significant or not. In various parts of the report (including the overall summary) it is stated that this difference was statisticallyOECD SIDS ALKANES, C 18

- 30 , CHLORO

44 significant, but in other places there are statements that no statistically signific ant differences were found.

In order to investigate these results further, a re

- analysis of the data from this study was developed by Thompson ( 200 7 ). The statistical analysis was carried out on the same dataset as summarised in the TNO ( Hooftman and Hen zen 1993) study and incorporated the dataset for a medium

- chain chlorinated paraffin that was also tested at the same time as the C 18

- 20 , 52% wt. Cl substance. The data were found to be normally distributed and the variances were homogenous, satisfying th e requirements for the use of ANOVA (with Dunnett’s procedure to maintain a family error rate of 0.05) to determine significant differences from the column control. Using this procedure, no significant difference was seen between the reproduction rate in the C 18

- 20 , 52% wt. Cl treatment group (or the medium

- chain chlorinated paraffin treatment group) and the column control. In addition, a further analysis was carried out comparing the treatment groups with the pooled control group (the combined blank cont rol and column control) and this again showed no statistically significant differences for the C 18

- 20 , 52% wt. Cl treatment group.

Overall, the results of the TNO (1993) study indicate that although a reduction in reproduction rate occurred in the study c ompared with the control group, the statistical significance of this reduction is marginal, and depends on the exact method used to analyse the data. Either way the study can be interpreted as showing a NOEC (or a response close to a NOEC) at a concentrat ion of 2 μg/ L; the limit dose of the study. As this is a single value, dose response could not be determined from this study

.
Frank (1993) conducted a 21

- day reproduction stud y using dilutions of the water soluble fractions of two stock solutions (100m g/l and 10 g/l loading rates) of a C 18

- 20 52% Cl LCCP . The dilutions used were 1:2, 1:4, 1:8 and 1:16 for the 100 mg/l loading and 1:4, 1:8, 1:16, 1:32 and 1:64 for the 10 g/l loading. In these experiments, the test medium was changed 3 times/week and 10 animals per concentration were used. The tests were carried out at 20°C and a pH of 7.79

- 8.44. Two end

- points were determined in the study: effects on parent mortality and effects on reproduction (number of offspring/adult). Parent mortality in the con trols was 0% in the test carried out with the 10 g/l nominal stock solution and 10% in the test carried out with the 100 mg/l nominal stock solution. Elevated mortality was seen in the exposed populations: for the 10 g/l stock solution the LOEC was determi ned as the 1:8 dilution (approximately 58

- 65 μg/l) and the NOEC was determined as the 1:16 dilution (approximately 29

- 32 μg/l); for the 100 mg/l nominal stock solution the LOEC was determined as the 1:4 dilution and the NOEC was determined as the 1:8 dilut ion ( concentrations were measured by AOX (adsorbable organic halogen) analysis ; based on the detection limit for the analysis of the stock solution, these dilutions equate to LOEC and NOEC of <5 and <2.5 μg/l respectively). From the dose response curves it appears that 100% parent mortality occurred at concentrations of around <10 μg/l in the 100 mg/l nominal stock solution experiments and around 125 μg/l in the 10 g/l nominal stock solution experiments.

For the reproduction end point, the average number of young per adult in controls was 72.3 (variability 17.8%) in the 100 mg/l nominal stock solution series of experiments and 73.5 (variability 6.2%) in the 10 g/l nominal stock solution experiments. A significant reduction in the number of young per adul t was seen in some of the exposed organisms. For the 100 mg/l nominal stock solution, this effect on reproduction was significantly different from the control groups at the lowest concentration tested (a 1:16 dilution which is equivalent to a chlorinated paraffin concentration of <1.2 μg/l, based on the detection limit of the analytical method used). Thus the NOEC/LOEC for this series of experiments was <1.2 μg/l. Similarly, for the 10 g/l nominal stock solution effects were again seen at the lowest conc entration tested (a 1:64 dilution, which is equivalent to a chlorinated paraffin concentration of 7.3

- 8.1 μg/l). This value is treated as the LOECOECD SIDS ALKANES, C 18

- 30 , CHLORO

45 for this series of experiments. The report also indicates that the NOEC is very close to this value since u sing a different statistical method, the Dunnett

- Test rather than the Williams

- Test, the effects seen at this concentration were not statistically significantly different from controls.

The same 21

- day results were reported by Frank and Steinhäuser (1994) . In addition, this paper also reports the results of a similar test carried out using the water soluble fraction from a 1 mg/l nominal stock solution. This stock solution appears to have been prepared in a different manner from those previously. A solu tion of the chlorinated paraffin in pentane was prepared and a portion of this was added to the water, followed by stirring for 1 hour at 40°C to evaporate the solvent, prior to filtration. This showed no effects on parent mortality or reproduction in the test. However, it was not possible to determine the concentration of AOX (and hence chlorinated paraffins) present in these solutions, and so the actual exposure concentration is unknown.

There are a number of significant deficiencies in the studies by Frank (19 9 3) and Frank and Steinhäuser (1994) that make these data very difficult to interpret in terms of the effects of the C 18

- 20 liquid chlorinated paraffins (UK EA 200 9 ). However, t he raw data from t he 21

- day Frank (1993) and the Frank and Steinhäuse r (1994) studies have been obtained and reanalysed (Thompson, 2001 ) and discussed at length in the UK Environmental Risk Assessment of LCCPs (UK EA 2009)

. The analysis of these data suggest that while there are de ficiencies, they were useful in developing the predicted no effect concentration ( PNEC ) of 2.9 μ g/L for C 18

- 20 LCCPs (UK EA 2009)

. Chronic Toxicity to Mussel

The toxicity of two LCCP s to the common mussel ( Mytilus edulis ) has been determined over 60 days (Madeley and Thompson, 1983a and 1983b) . The compounds tested were the same C 22

- 26 , 43% wt. Cl and a C >20 , 70% wt. Cl products (mixed with a small amount of radiolabelled

n

- pentacosane that had been chlorinated to a similar degree) as used in the 60

- day rainbow trout study by Madeley and Thomp son . The test used a flow

- through system with filtered natural seawater (salinity 35‰, pH 8.0

- 8.3, dissolved oxygen 6.1

- 8.25 mg/l) at 15°C. Acetone was present in the test solutions at a concentration of 0.5 ml/l (500 ppm), and acetone controls were also run using this concentration. Groups of 30 mussels were used for each exposure concentration ; the mussels were fed during the test (algal cells were added to the in

- flowing water at a rate of 1.0

- 1.1 x 10 9 cells/day).

For the C 22

- 26 , 43% wt. Cl substance two nominal concentrations of 0.32 mg/l and 3.2 mg/l were tested. The mean measured concentrations for these two exposures over the duration of the test were determined as 0.12 mg/l and 2.18 mg/l respectively by 14 C

- analysis. Measurements by parent
compo und analysis (using a TLC method) at various times during the test were in general agreement with these values. The 2.18 mg/l exposure solution was reported to be cloudy in appearance, with a fine white deposit being observed, indicating that the solubili ty of the substance in the test system had been exceeded. No significant mortality occurred in the test. Reduced filter feeding activity compared to control populations was consistently observed in the 2.18 mg/l exposure group from the 7th day onwards, a nd it was thought that this may reflect a response to the "particulate" nature of the test solution.

For the C >20 , 70% wt. Cl substance, the two nominal concentrations tested were 0.56 mg/l and 1.8 mg/l. The mean measured concentrations at these two expo sures were determined as 0.46 mg/l and 1.33 mg/l by 14 C

- measurements. Occasional parent compound analyses were in general agreement with these values. Some deposition of the test substance was noted at the highest concentration, indicating that the solub ility of the substance in the test system had been exceeded. No mortality as a result of exposure to the chlorinated paraffin was seen in the test. Again, reduced filtration activity was seen in the 1.33 mg/l exposure group when compared with the control populations,OECD SIDS ALKANES, C 18

- 30 , CHLORO

46 particularly during the second half of the exposure period. However, this observation was variable, and on a number of occasions the filter feeding activity was comparable to controls and so this reduction in activity was considered to be mi nimal and tentative.

4.2 Terrestrial Effects
There are no toxicity studies available for LCCPs on soil

- dwelling or avian organisms. However, data on other c hlorinated paraffins show low toxicity to terrestrial species.

4.3 Initial Assessment for the Environment

LC CPs have low volatility and water solubility. Based on Mackay Level III fugacity modelling, in the environment LCCPs are expected to migrate almost entirely to the soil when released to the air or soil and to the sediment when released to the water. The l imited amount of LCCPs that stay in the air would break down via photooxidation mediated primarily by hydroxyl radicals with a calculated degradation half

- life range of 18 to 112 hours (based on a 12

- hour day and a hydroxyl radical concentration of 5x10 5 O H /cm 3 )

. For LCCPs in the soil and sediment, while these materials would not be considered readily biodegradable, there is some information that microorganisms may consume these substances over time. LCCPs do not appear to be toxic microorganisms in the

a vailable study data

.
There is a relatively large amount of aquatic toxicity data available for LCCPs ; the key chronic data

are summarized i n Table 19 below . The substance generally shows little or no toxicity at concentrations well in excess of its water solubility in acute tests. Effects have been seen on Daphnia at high concentrations in acute tests , but these are likely to be physical effects rather than direct toxicity of the substance itself. No valid algal study exists for LCCPs, but data from rela ted chlorinated paraffins and the overall toxicity profile of these substances suggest that filling this datagap is not critical for the environmental assessment. Daphnia magna have been identified as the most sensitive species for chlorinated paraffins as a substance class. Although there is uncertainty with data interpretation given the difficulties testing LCCPs, available chronic studies with Daphnia
magna indicate that effects are unlikely to be observed below the limit of water solubility for C 20

- 30 ( liquid and solid) LCCPs. Two studies are available which investigated chronic toxicity to Daphnia
magna from C 18

- 20 LCCPs. These ga ve conflicting evidence, one showing no effects at saturation and the other indicating effects around the limit of water solu bility. Interpretation of aquatic test results is complicated by the difficulties associated with test media preparation and analysis

, resulting from the complex nature of the materials and their low water solubility.OECD SIDS ALKANES, C 18

- 30 , CHLORO

47 Table 19 : Summary of Key Chronic A quatic Toxicity Data for LCCPs Substance Species Exposure Value Rel. Reference
C18

- 20 (liquid)
C 18

- 20 , 52% wt. Cl Daphnia magna 21 days No statistically significant effects observed at 2 μg/L ( measured ) (based on re

analysis by Thompson) 2 Hooftman and Henzen/ TNO 1993 Thompson 2005

C 18

- 20 ; 52% wt. Cl Daphnia magna 21 days ~29

– 32 ug/l (NOEC) (measured) 2 Frank (1993); Frank and Steinhäuser (1994) C20

- 30 (liquid)
C18

- 26; 49% Cl Alburnus alburnus 91 days (accumulation period) & subsequent 316 days ( elimination period) LC0 > 3400 mg/L

(nominal) 2 Bengtsson & Baumann (1982). UK Environment Agency (2008). C22

- 26; 43% Cl Oncorhynchus mykiss / Salmo gairdneri 60 days NOEC = 4 mg/L

(nominal) 2 Madeley & Maddock (1983a).

C22

- 26; 43% Cl Mytilus edulis 60 days NOEC: 2.18 mg/L LOEC: 2. 18 mg/L (nominal) 2 Madeley & Thompson (1983b) C25; 43% Cl Daphnia magna 21 days NOEC = 55 ug/L LOEC > 55 ug/L EC50 > 55 ug/L (measured) 1 Sharpe & Penwell (2007)

C20

- 30 (solid)
C20

- 30 ; 70% Cl Oncorhynchus mykiss / Sal mo gairdneri 60 days NOEC = 3.8 mg/L 2 Madeley & Maddock (1983b).

C20

- 30 ; 70% Cl Mytilus edulis 60 days NOEC: 1.33 mg/L LOEC: 1.33 mg/L 2 Madeley & Thompson (1983a)OECD SIDS ALKANES, C 18

- 30 , CHLORO

48 

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