OECD SIDS

1-OCTADECANOLFOREWORDINTRODUCTION

1-OCTADECANOLCAS N°: 112-92-5

UNEP PUBLICATIONS

21

Identifiers, Physical and Chemical properties

Substance
End Point
Chemical Name
Common Name
CAS Number
RTECS Number

:
:
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:

IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES
1-Octadecanol
Stearyl alcohol
112-92-5
RG2010000

Synonyms
Aldol 62
Atalco S
CO 1895F
Conol 30F
1-Hydroxyoctadecane
Lanol S
Octadecanol
Octadecyl alcohol
Siponol S
Stearol

Alfol 18
Cachalot S 43
Conol 1675
Crodacol S
Kalcohl 80
Lorol 28
n-Octadecanol
Sipol S
Siponol SC
Steraffine

Properties & Definitions
Molecular Formula
Molecular Weight
Melting Point
Boiling Point
Flash Point
Density
Vapour Pressure
Octanol/Water Partition
Coefficient
Water Solubility
Solubility in other
Solvents
Impurities

General Comments

:
:
:
:
:
:
:
:

C18H38O::

1.1E-3mg/l at 34C:

Up to 10% of impurities. Variable amounts of n-hexadecanol,
n-tetradecanol, n-eicosanol and n-dodecanol. Maximum 2%stearyl stearate, 1% octadecane, 0.5% stearic acid and totalhydrocarbons at about 1.8%.
MP of commercial product = 56-60C and calculated VP= 1.93E-6mmHg arealso reported. Presents a moderate fire hazard when exposed to heat or flame.
Autoignition temperature = 450C. Adsorption coef. (Log Koc = 5.81 calculated).

:

270.50
59.8C
336C
170C
0.8124 at 59C
0.133kPa (1mmHg) at 150.3C
log Pow = 8.22 (calculated)

Soluble in alcohol, acetone, ether, benzene, chloroform

Overall Evaluation
SIDS INITIAL ASSESSMENT
There is need for further work.
SHORT SUMMARY OF THE REASONS WHICH SUPPORT THE RECOMMENDATIONThe substance is firmly bound to sediments, and therefore anaerobic biodegradation can be an important factor.
A 21-day test in daphnids indicated that the substance may be toxic at a range of between 1 and 3mg/l.
FURTHER WORK RECOMMENDED:
Determination of anaerobic biodegradability. Depending on the results of this test, it may be considered whether
or not long-term fish toxicity testing is required.
IRPTC Data Profile

22

Production-Trade

Production-Trade
Chemical Name
CAS Number
Geographic Area:::

1-Octadecanol
112-92-5

General Comments:

In the United States production of detergent range alcohols including
octadecanol was 354000 tonnes in 1987.

USA

References!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 7, (1993)

Production-Trade
Chemical Name
CAS Number
Geographic Area:::

1-Octadecanol
112-92-5

General Comments:

According to Danish trade statistics, national use and manufacture of lauryl,stearyl and cetyl alcohols was in the range of 1000 to 10000 tonnes in 1986.

DNK

References!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 6, (1993)

IRPTC Data Profile

Uses

23

Uses
Chemical Name
CAS Number::

1-Octadecanol
112-92-5

Geographic Area

:

USA

Use
QuantityYear

Comments

1981

Reported as being used in 425 cosmetic formulations
at the above range of 0.5 to 50%.

References
Primary References:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 1-29,(1985)

Secondary References:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 7, (1993)

Chemical Name
CAS Number::

1-Octadecanol
112-92-5

Geographic Area

:

DNK

Uses

Use
QuantityYear

Comments

1992

Registered in 47 non-cosmetic products on the Danish
market.

References
Secondary References:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 6, (1993)

Chemical Name
CAS Number::

1-Octadecanol
112-92-5

Geographic Area

:

USA

Uses

1981

Unspecified amount used in pharmaceuticaldispensing, cosmetic creams, emulsions, textile oils
and finishes, antifoam agent and as a chemical raw
material.

IRPTC Data Profile

24

Uses

References
Primary References:

12VXA5Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, 10, 1259,(1983)

Secondary References:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 7, (1993)

IRPTC Data Profile

Pathways into the Environment and Environmental Fate

25

Study
End Point
Chemical Name
CAS Number:::

Pathway into the Environment and Environmental Fate.
1-Octadecanol
112-92-5

Pathway and Transport
Pathway
Pathway description

:
:

NATUR
Persumably of natural origin, has been isolated from plants and insects, fromhuman sebaceous lipids, and has been found in mammalian glands andorgans.

Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 1-29,(1985)

Secondary Reference:!SIDSP*
Screening Information Data Set (SIDS) of OECD High Production Volume
Chemicals Programme, 10, (1993)

References

Study
End Point
Chemical Name
CAS Number:::

Pathway into the Environment and Environmental Fate.
1-Octadecanol
112-92-5

Test Method and Conditions
Test method
description
Temperature:

Mackay level 1 Environmental Partitioning Model

:

25 C

Quantity Transported
Mediumto Medium

Quantity

Time

Year

to YearAIR
0.45 %
Into air according to Mackay level 1 model (ML1EP)
SOIL
Into soil (according to ML1EP)

51.43 %

AQ
Into water (according to ML1EP)

0.00 %

AQ
Into suspended solids (according to ML1EP)

0.08 %AQ
Aquatic biota (according to ML1EP)

0.03 %

SED
Sediment (according to ML1EP)

48.00 %

General Comments:

Above values are all calculated. Environmental partitioning will be almost
exclusively onto soils and sediments.
IRPTC Data Profile

26

Pathways into the Environment and Environmental Fate

References
Secondary Reference

IRPTC Data Profile:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1993)

Concentration

27

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

CONCENTRATION
1-Octadecanol
112-92-5

ESP

Test Subject
Organism Medium
AQ

Specification Lifestage Sex
FRESHSpecies/strain/system

River water entering water works near Barcelona, Spain.

:

Test Method and Conditions
Test method
description

FAB mass spectrometry:

Test Results
MatrixConcentrations

Spec.

Date

1-Octadecanol has been identified but the concentration was not determined.

References
Primary Reference:

WRERAQ
Ventura, F. et al. Water Resources Research, 23(9), 1191, (1989)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 10, (1993)

Study
End Point
Chemical Name
CAS Number:::

CONCENTRATION
1-Octadecanol
112-92-5

Test Results

General Comments:

Environmental partitioning will be almost exclusively onto soils andsediments. Stearyl alcohol (presumably of natural origin) has been isolated
from plants and insects, from human sebaceous lipids and has been foundin mammalian glands and organs. (ref. Journal of the American College of
Toxicology. vol.4, no.5, 1985. pp.1-29)

IRPTC Data Profile

Concentration

28

References
Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 10, (1993)

:
:
:
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CONCENTRATION
1-Octadecanol

Study
End Point
Chemical Name
CAS Number
Geographic Area

112-92-5

USA

Test Subject
Organism Medium
AQ

Specification Lifestage Sex
INDSTSpecies/strain/system

Industrial effluent discharged into the Illinois river.

:

Test Results
MatrixConcentrations

Spec.

Date

1-Octadecanol has been identified but the concentration was not determined.

References
Primary Reference:

JTEHD6
Somani, S. et al. Journal of Toxicology and Environmental Health, 6,315-331, (1980)

Secondary Reference:!SIDSP*
Screening Information Data Set (SIDS) of OECD High Production
Volume Chemicals Programme, 10, (1993)

:
:
:
:

CONCENTRATION
1-Octadecanol

Study
End Point
Chemical Name
CAS Number
Geographic Area

112-92-5

USA

Test Subject
Organism Medium

Specification Lifestage Sex

AIRSpecies/strain/system

IRPTC Data Profile:

Indoor aerosol samples from large building in U.S.A. Particle sizes from
1.1 to 2um.

Concentration

29

Test Method and Conditions
Test method
description

GC-MS

:

Test Results
MatrixConcentrations

Spec.

Date

1-Octadecanol has been identified but the concentration was not determined.

References
Primary Reference:

ESTHAG
Weschler, C. Environmental Science and Technology, 14(4), 428-431,(1980)

Secondary Reference:!SIDSP*
Screening Information Data Set (SIDS) of OECD High Production
Volume Chemicals Programme, 10, (1993)

IRPTC Data Profile

Human Intake and Exposure

30

Study
End Point
Chemical Name
CAS Number:::

HUMAN INTAKE AND EXPOSURE
1-Octadecanol
112-92-5

Test Subject
Organism Medium

Specification Route Lifestage Sex

HUMAN

Test Results
Intake

Spec.

Date

1-5 mg/d
Expected daily exposure through use of consumer products (cosmetics)
0.015-0.075 mg/kg
BW
Expected daily exposure for a person weighing 70kg.
<1 mg/dIngested per day as 1-octadecanol as an ingredient in lipsticks
3782 mg/y
An annual dermal potential dose with 5% content in a bar of soap used daily (according to the U.S. EPA dermal
model, worst case scenario).

General Comments

There are many sources of potential consumer exposure. The most intense
probably being through the use of creams and cosmetics. Inhalation isunlikely to be a significant exposure route. (See evaluation of the healthaspects of stearyl alcohol as a food ingredient, FDA 223-78-2100, 1980).

:

References
Secondary Reference

IRPTC Data Profile:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1993)

Biodegradation

31

Study
End Point
Chemical Name
CAS Number
Study type

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:
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BIODEGRADATION
1-Octadecanol:

2-16 d112-92-5

LAB

Exposure
Exposure Period

Test Results
Quantity

Time

Comments on result
BOD: T/2 ranges from 2 to 16 days. (Painter 1974)
COD

100 mg/l
67 %BOD/COD

28 d

General Comments:

The manufacture considers this as evidence of "ready" biodegradability.
However, this test requires continuous shaking, and, as only 67% of thesubstance had been degraded at the conclusion of the test, the result
may better be thought of as an indication of "inherent" biodegradability.
Possibly the very low solubility of the test substance (0.0011g/l at 34C)
limits bioavailability and thus ready degradation. The test result canperhaps best be interpreted as being near the bordeline between readyand inherent biodegradation.

:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1993)

References
Secondary Reference

IRPTC Data Profile

32

Hydrolysis

Study
End Point
Chemical Name
CAS Number
Study typeMediumSpecifications

:
:
:
:
:
:

HYDROLYSIS
1-OctadecanolTime

Comments on result112-92-5

LAB
AQ
FRESH

Test Results
Quantity

Hydrolysis T/2 estimated at 1000 days (practically inert).

50 %References
Primary Reference:

HKBAD*
Henkel. Bestimmung der Akuten Daphientoxizitat von Octadecanol im
Daphnietest nach DIN 38412 (Test of Octadecanol on Acute Toxicity toDaphnia according to DIN 38412), 01(2), (1988)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 4, (1993)

IRPTC Data ProfileSorption

33

Study
End Point
Chemical Name
CAS Number:::

SORPTION
1-Octadecanol:

The water solubility of this substance is too low to allow a reliable
estimate of partitioning. Can be expected to bind strongly to soils,
sediments and particles.

Primary Reference:

XQSAR*
Veith, G. et al. EPA QSR System, Environmental Research Lab (ERL),(1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 9, (1993)

112-92-5

Test Results
General Comments

References

IRPTC Data Profile

Absorption

34

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

ABSORPTION
1-Octadecanol
112-92-5

LAB

Test Subject
Organism Medium

Specification

BIRD

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

ORL

ADULT

:

White Leghorn chickens

:
:
:

SHORT
10 % DIET
Feeding studies with 1-octadecanol at 10% in the diet, to determine
digestibility

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Quantity Absorbed

Time

Comments on result
Digestibility was determined as 0%

References
Primary Reference:

JAFCAU
ANON. Journal of Agricultural and Food Chemistry, 35(10), 1610-16,(1971)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27, (1993)

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

ABSORPTION
1-Octadecanol
112-92-5

LAB

Test Subject
Organism Medium

Specification

RAT

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

ORL
PAR

:

Sprague-Dawley rats:

1-Octadecanol labelled with C14

Test SubstanceLabelled Compound
IRPTC Data Profile

Absorption

35

Exposure
Exposure Type
Exposure comments

:
:

SHORT
Test substance was labelled with C14 and administered via duodenal oraortic cannula. Blood and lymph were monitored at intervals up to 24h.
Distribution of radioactive substance and biochemical analyses were
examined.

Test Results
Quantity Absorbed

Time

Comments on result
Absorption of the compound appeared to be a function of its lipid
solubility. 56.6% (+/- 14%) was in the lymph. Of this more than half was
found in the triglycerides, 6-13% in phospholipids, 2-8% in cholesterolesters, 4-10% unchanged as octadecanol.
90% of the octadecanol was carried in the chylomicron fraction of blood.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 129, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27, (1993)

IRPTC Data Profile

Distribution

36

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

DISTRIBUTION
1-Octadecanol
112-92-5

LAB

Test Subject
Organism Medium

Specification

BIRD

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

ORL
PAR

ADULT

:

White leghorn chickens:

1-Octadecanol. C14

:
:

SHORT
C14 labelled test substance was administered through duodenal or aortal
cannula, blood and lymph were monitored at intervals up to 24h.
Distribution of radioactive substance was measured.

Test SubstanceLabelled Compound

Exposure
Exposure Type
Exposure comments

Test Results
Organ Quantity-------- ------------Time
Comments on result--------------- -------------------------------

INT

Analysis of homogenated intestinal wall showed 56.6%(+/-14%) of the substance present in the lymphatic
system of the intestine.

BLOOD

Analysis of blood compartments showed 90% of test
substance in the chylomicron fraction.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 129, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27, (1993)

IRPTC Data Profile

Bioconcentration

37

Study
End Point
Chemical Name
CAS Number:::

BIOCONCENTRATION
1-Octadecanol
112-92-5

Test Results
Bioconcent.
Organ Factor--------- -----------------

Calc
Basis Time
State Comments on result--------- ----------------- -------- ------------------------------Calculated results based on method of Veith, G. et al.
(1980).

100000:The water solubility of this substance is too low to allow a reliable
estimate of partitioning.

Primary Reference:

XQSAR*
Veith, G. et al. EPA QSR System, Environmental Research Lab (ERL),(1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 9, (1993)

General Comments

References

IRPTC Data Profile

Metabolism

38

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

METABOLISM
1-Octadecanol
112-92-5

LAB
DNK

Test Subject
Organism Medium

Specification

RAT

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

ORL
PAR

:

Sprague-Dawley rats:

C14 labelled 1-octadecanol

:
:

SHORT
C14 labelled 1-octadecanol was administered via duodenal or aortal
cannula. Blood and lymph were monitored at intervals up to 24h post
administration. Distribution and biochemical analysis were assessed.

Test SubstanceLabelled Compound

Exposure
Exposure Type
Exposure comments

Test Results
Organ Quantity-------- ---------------Time
Comments on result------------------ ------------------------------From the absorbed fraction more than half was
metabolized to triglycerides, 6-13% to phospholipids, 28% to cholesterol esters, and 4-10% remained as
unchanged octadecanol after 24h period, from dosing.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 129, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27, (1993)

IRPTC Data ProfileMammalian Acute Toxicity

39

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
1-Octadecanol
112-92-5

Species/strain/system
Dose / Concentration::

Wistar rats
5.0 g/kg

Test Method and Conditions
Test method
description

OECD No. 401, Limit test.

:

Test Results
Organism Medium

Spec.

Lifestage Sex

Effect Effect Comments

LD50 Oral LD50 for wistar rats was estimatedas >5.0g/kg/body weight.
No mortality among the experimental animals at the dose up to 5.0g/kg/bodyweight.

RAT

General Comments

Route
ORL

:

References
Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 17, (1993)

IRPTC Data ProfileMammalian Toxicity

40

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
1-Octadecanol
112-92-5

Test Subject
Organism Medium

Specification

Route

RAT

Species/strain/system

Lifestage Sex Number exposed Number controls

IHL
Strain not indicated:Test Method and Conditions
Test method
description:

The rats were exposed by inhalation of 10% 1-octadecanol in 55% ethanol for
2-hours. OECD fixed dose test guidelines for variable duration of testing.

:
:

2h
10 %

Exposure
Exposure Period
Dose / Concentration

Test Results
LC50 for acute inhalation toxicity was not established under the experimental conditions.
The exposure was reported to be without effect. No further details were
General Comments:
provided.

References
Secondary Reference

IRPTC Data Profile:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 17-18, (1993)

Mammalian Toxicity

41

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MAMMALIAN TOXICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system:

Sprague-Dawley rats strain:

Olive oilM
F

10/DOSE
10/DOSE

10
10

Test Substance
Vehicle - Solvent

Test Method and Conditions
Test method
description:

OECD Guideline No. 407; a 28-day oral Toxicity Test (Repeated Dose Toxicity
Test).

:::

28 d
100-1000 mg/kg BW
Ten animals per each sex per dose received: 0 (negative control), 100, 500 or
1000mg/kg/body weight per day in oral gavage, preparation of 1-octadecanolin olive oil for 28 days.

Exposure
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

NEF
Dose at which no toxic effects were observed was concluded to be >1000mg/kg/body weight per day.
There was no substance related effects: no effects noted on biochemical
General Comments:
anatomical or histopathological parameters. No cummulative effects wereobserved after 28 days of daily oral administration of 1-octadecanol up to
1000mg/kg/body weight per day.

References
Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 20, (1993)

IRPTC Data ProfileMammalian Toxicity

42

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MAMMALIAN TOXICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

SKN

10/DOSE

RBTSpecies/strain/system:

Rabbit, strain unspecified:

Cream containing 8% of tested substance.

10

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description

OECD Guidelines for Repeated Dose Toxicity-Dermal:

Exposure
Dose / Concentration
Exposure comments::

8.8-13.2 mg/cm2
2 groups of 10 animals each received topical applications of the creamcontaining 8% 1-octadecanol 3d/wk for 3 months. One group received a doseof 8.8mg/cm2 on 8.4% of body surface, the other group received 13.2mg/cm2
on 11.2% of body surface. 10 animals served as untreated control.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

SKIN

CIRC
STRUC
The product caused slight to well defined erythema and mild desquamation during the first month of treatment.
SKIN
STRUC
At necropsy symptoms of mild inflammation at the application site were reported.
Apart from local changes there was no evidence of systemic toxicity
General Comments:
attributable to topical exposure of 1-octadecanol. No treatment related effects
were found in hematological and blood chemistry determinations, urinanalysis,organ weight measurements at necropsy.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 14, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 20-21, (1993)

IRPTC Data Profile

Carcinogenicity

43

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CARCINOGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

MOUSE

Route

Lifestage Sex Number exposed Number controls

SKN

Species/strain/system

F

30

:

Swiss mouse strain

:

97%

:
:

0.4 mg30 female mice were treated to test dermal carcinogenicity potential ofoctadecanol. Skin was pretreated with dimethylbenz(a)anthracene andthereafter treated with 20ul of octadecanol in cyclohexane, 3x week for 60
weeks (about 0.4mg of octadecanol/application).

Test SubstancePurity Grade

Exposure
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

SKIN
STRUC
F
1 local papilloma was observed among 23 surviving animals, (appearing at week 30).
The authors state that the initiation dose alone is non-carcinogenic, andGeneral Comments:
conclude that octadecanol is probably a weak tumor-promoter. OECD/SIDS
comment: "The unconventional design of the test, and small number ofanimals involved make the results difficult to interpret".

References
Primary Reference:

TXAPA9Sice, J. Toxicology and Applied Pharmacology, 8, 70-74, (1966)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 24-25, (1993)

IRPTC Data Profile

Carcinogenicity

44

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

CARCINOGENICITY
1-Octadecanol
112-92-5
DNK

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

PAR

56

MOUSE

Species/strain/system

42/GROUP

Strain unspecified:

Test Method and Conditions
Test method
description

OECD Guideline for Carcinogenicity Testing:

Exposure
Exposure comments:

The test substance was pressed into spheroidal pellets 5/32 inch in diameter,
weighting 24-27mg. Pellets were inserted into bladders of 56 mice. 330 days
after surgery all surviving animals were sacrificed and examined for theevidence of carcinoma. Animals surviving more than 175 days but less than
330 days were also evaluated.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

STRUC
CAR
In a total of 39 mice surviving more than 175 days, 7 benign tumors and 2 carcinomas of the bladder (5%)
were observed (1 stage II and 1 stage III tumor). There were no tumors, benign or malignant among the 3
control groups of 42 animals each which had not received bladder implants.
A number of other substances tested in this series also produced bladder
General Comments:
carcinomas. These included cholesterol, 8% tumor incidence and paraffin with
3% incidence of carcinoma.

References
Primary Reference:

CNREA8
Bryan, G. Cancer Research, 26, 105-109, (1966)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 25, (1993)

IRPTC Data Profile

Carcinogenicity

45

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CARCINOGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

MOUSE

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

IPR

4/GROUP

4:

Swiss albino ddy strain

:
:
:

5d
2.5-10 mg/kg/ dGroups of four 5-week old mice were implanted intra-peritonealy with Erlich
Ascites Tumor cells (1 million cells per mouse). After 24h, the mice were
exposed I.P. to doses of 2.5 or 10mg/mouse/day of octadecanol for 5
consecutive days.

Exposure
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Survival time was increased to >25.5 days in the 2.5mg group. The survival time was unchanged in the 10mggroup relative to untreated controls (18.0 days and 18.3 days respectively).
"The small number of animals used makes assessment of the possible
General Comments:
antitumor activity of octadecanol difficult".

References
Primary Reference:

CNREA8Ando, K. et al. Cancer Research, 32, 125-129, (1972)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 25-26, (1993)

IRPTC Data Profile

Mutagenicity

46

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MUTAGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system

Bacteria, Salmonella typhimurium, strains: TA98, TA100, TA1535,
TA1537:

Test Method and Conditions
Test method
description

Ames test:

Exposure
Dose / Concentration
Exposure comments

:
:

3umol
Ames test. The substance was spot tested at one concentration 3umol/plate =total of 815ug/plate in all strains, both with and without metabolic activation
with S-9.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No evidence of mutagenicity was seen in this test system.
There was a precipitation of the substance at concentration <3umol/plate
General Comments:(below the original concentration of the substance) making a validinterpretation of the results rather difficult.

References
Primary Reference:

TXCYAC
Florin, I. Toxicology, 18, 219-232, (1980)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 22, (1993)

IRPTC Data Profile

Mutagenicity

47

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MUTAGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system:

Bacteria, Salmonella typhimurium, strains: TA1538, TA1535
TA1537, TA100, TA98:

Stearyl alcohol from SIGMA chemical company

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description

Ames test:

Exposure
Exposure comments:

Ames test for spot testing of 1-octadecanol at concentration of 50mg/plate inall strains both with and without metabolic activation with S-9.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

NEF
There was no mutagenic activity observed under the condition of this test. There was no toxic effect reported
either with or without metabolic activation. There was no precipitation observed at the concentration used.
The conclusion drawn by the authors was that the concentration of theGeneral Comments:
substance tested was so low that the value of the test was not fully predictive.

References
Primary Reference:

JEHSDH
Blevins, R. et al. Journal of Environmental Sciences and Health, Part C,
Environmental Health Sciences, A17(2), 217-239, (1982)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 22-23, (1993)

IRPTC Data Profile

Mutagenicity

48

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MUTAGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system

Salmonella typhimurium strains: TA1535, TA1537, TA1538, TA98
TA100

:

Test Method and Conditions
Test method
description

Ames test.

:

Exposure
Dose / Concentration
Exposure comments::

0.63-20.0 ug/ PLATE
Concentrations of 0, 0.63, 1.25, 2.5, 5.0, 10.0 and 20.0 microgram/plate, wereused with and without metabolic activation by S9. All experiments were
performed twice, and results were averaged.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No significant increase in the number of histidine + revertants/plate relative to controls was observed at any
concentrations tested, with and without metabolic activation.

References
Primary Reference:

NKEZA4
Hacmiya, N. Japanese Journal of Public Health, 29(5), 236-239, (1982)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 21-22, (1993)

IRPTC Data Profile

Mutagenicity

49

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

MUTAGENICITY
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

ORL

6/DOSE

MOUSE

Species/strain/system:

Strain not specified:

Olive oil6

Test Substance
Vehicle - Solvent

Test Method and Conditions
Test method
description

Micronucleus test. Japanese Guidelines of testing.

:Exposure
Dose / Concentration
Exposure comments::

0.36-1.45 g/kg BW
Groups of six mice each received single oral dose of 0.36, 0.73 or 1.45g/kg
body weight. An additional group of five mice received four doses (oral) of
0.73g/kg body weight of tested substance.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

NEF
There was no evidence of genotoxic effect according to the authors.

References
Primary Reference:

NKEZA4
Hacmiya, N. Japanese Journal of Public Health, 29(5), 236-239, (1982)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 24, (1993)

IRPTC Data Profile

Sensitization

50

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

SENSITIZATION
1-Octadecanol
112-92-5
DNK

Test Subject
Organism Medium

Specification

GPIG

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

SKN

25

5/GROUP:

Guinea pigs, strain not specified:

Deodorant containing 24% of 1-octadecanol:Petrolatum

:
:

12 %
Draize repeated topical application method consisting of 9 induction
applications, 14-day period without treatment followed by the challenge
applications for determination of skin sensitization. Controls for petrolatum anduntreated animals.

Test SubstanceDescription of the test
substance
Vehicle - Solvent

Exposure
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

SKIN

ALLER
1/25
1/5
INC
One of 25 treated animals exhibited an equivocal score 24 hours post application to intact skin sites.
One of 5 petrolatum control animals showed an equivocal reaction score 24 hours post application to intact
skin sites.
The authors concluded that 1-octadecanol was not a contact sensitizer atGeneral Comments:
concentration of 12% in petroleum from an unidentified deodorant (containing
24% of the tested substance) preparation as a source of 1-octadecanol.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 18, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 19-20, (1993)

IRPTC Data Profile

Sensitization

51

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

SENSITIZATION
1-Octadecanol
112-92-5
DNK

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

SKN

172-824

HUMAN

Test Substance
Vehicle - Solvent:

Petrolatum

Test Method and Conditions
Test method
description:

According to North American Contact Dermatitis Group Study Designs.

:
:

1-4 y
Patch test with 30% stearyl alcohol in petrolatum was assessed after 48 and96 hours. The test was conducted during several one-year periods on large
numbers of human subjects.

Exposure
Exposure Period
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

SKIN
ALLER
2/172
In 1975-1976 one-year study out of 172 tested. 2 showed allergic reaction (1.2%)
SKIN
ALLER
1/446
In 1976-1977 one-year study out of 446 tested. 1 showed allergic reaction (0.22%)
SKIN
ALLER
6/634
In 1978-1979 one year study out of 824 tested. 6 showed allergic reaction (0.73%). In 1979-1980 one year
study out of 634 tested. 6 showed allergic reaction (0.95%)
There were several other studies performed testing skin sensitization potential
General Comments:of stearyl alcohol (1-octadecanol). The results were negative for skinsensitization. According to the authors, the positive results above indicate avery mild sensitization potential.

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 1-29,(1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27-28, (1993)

IRPTC Data Profile

Irritation

52

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

IRRITATION
1-Octadecanol
112-92-5
LAB
DNK

Test Subject
Organism Medium

Specification

HUMAN

Route

Lifestage Sex Number exposed Number controls

SKN

80

Exposure
Exposure Type
Dose / Concentration
Exposure comments

:
:
:

ACUTE
100 %
Single insult occulsive patch test using 100% stearyl alcohol. Assessment after
24 hours.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

SKIN
IRRIT
A mild irritation was found in one out of 80 human subjects.

Sex-------

Affected in
Exposed - Controls----------------------------1/80

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 1-29,(1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 27, (1993)

:
:
:
:
:

IRRITATION
1-Octadecanol
112-92-5
LAB
DNK

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

Test Subject
Organism Medium

Specification

RBT

Species/strain/system

IRPTC Data Profile

:

Route

Lifestage Sex Number exposed Number controls

EYE

6

Rabbit, strain not specified

Irritation

53

Exposure
Exposure Type
Exposure comments

:
:

ACUTE
Undiluted 1-octadecanol from four separate commercial sources was instilled
full strength into one eye of each of the experimental animals. The irritation
was scored on the scale of 0-110.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

EYE
IRRIT
1 d
Minimal irritation was noted on day one for three of the samples tested. Maximum score of 5 (scale 0 - 110)
was reported. There was no irritation reported for the remaining sample. Scores decreased to 0 by day 4.
The results were classified by the authors as minimal eye irritation.
General Comments:

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 14-15,(1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 19, (1993)

:
:
:
:
:

IRRITATION
1-Octadecanol
112-92-5
LAB
DNK

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

Test Subject
Organism Medium

Specification

RBT

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

SKN

ADULT

9

:

Rabbit, strain not specified

:
:

ACUTE
Each sample was applied in full strength under occlusion to the clipped skin for
24 hours.

Exposure
Exposure Type
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

SKIN
IRRIT
Irritation scores of 0.4, 0.5, 1.42 and 1.5 (scale 0 - 4) were recorded after 24 hours of full strength exposure.
The results were interpreted by the authors as indicating minimal to mild
General Comments:
primary skin irritation.

IRPTC Data Profile

54

Irritation

References
Primary Reference:

JACTDZ
ANON. Journal of the American College of Toxicology, Part A, 4(5), 15, (1985)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 18-19, (1993)

IRPTC Data Profile

Reproduction

55

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

REPRODUCTION
1-Octadecanol
112-92-5
DNK

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system:

Wistar (Mol/WIST) SPF strain:

1-Octadecanol (Sigma L 5751)

:

99%

M
F

Test SubstanceDescription of the test
substance
Purity Grade

Test Method and Conditions
Test method
description:

OECD - Combined Repeated Dose and Reproductive/Developmental Toxicity
Screening. GLP: YES.

:
:
:

SHORT
100-2000 mg/kg BW
The doses of 0, 100, 500 or 2000mg/kg body weight/day was administered in
the diet.

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No observed effect level for parental animals was determined to be more than the highest dose tested>2000mg/kg body weight/day.
OFSPR
NEF
NOEL for F1 generation was established as >2000mg/kg body weight/day
1-Octadecanol administered orally in the diet at dosages up to 2000mg/kg
General Comments:
body weight/day did not cause any toxic effect on reproduction or on thehaematological and pathological parameters investigated under the test
conditions.

References
Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 26, (1993)

IRPTC Data Profile

Aquatic Acute Toxicity

56

Study
End Point
Chemical Name
CAS Number:::

AQUATIC ACUTE TOXICITY
1-Octadecanol
112-92-5

Species/strain/system
Exposure Period
Dose / Concentration:::

Mosquito (Aedes aegypti) age: 2-14 days
24-72 h8.2-101 ml/m2

Test Method and Conditions:

Hexane was used as solvent in both tests. The solvent itself showed noharmful effects on the larvae. See under general comments for details.

:

25-27 C

Organism Medium

Spec.

Route

INSEC

FRESH

Test method
description
Temperature

Test Results
AQ

General Comments

Lifestage Sex

Effect Effect Comments

EGG
LARVA

LD50 LD50 eggs = 8.2ml/m2; LD90 eggs =14.5ml/m2; LD50 juvenile,(1-4th instar
larvae, pupae) = 23.4-77.1ml/m2; LD90
juvenile,(1-4th instar larvae, pupae) =28.1-101.0ml/m2

PUPA
Mortality based on difference between larval count, between control and study
group. LD50 based on field application of litre/hectar. Eggs were immersed in
150ml of hay infusion in jars of 51cm2 surface area. 150-250 embryonatedeggs per jar. Each trial carried out in triplicate at 10 different concentrations.
Each series of tests repeated 10 times. Larvae and pupae, 25 of each treatedas above with minimum of 5 different concentrations of test substance, eachseries of tests repeated 10 times. Mortality interpreted as failure of larvae to
move.

:

References
Primary Reference:

TRSTAZ
Transactions of the Royal Society of Tropical Medicine and Hygiene, 77(1), 3538, (1983)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 14, (1993)

Study
End Point
Chemical Name
CAS Number:::

AQUATIC ACUTE TOXICITY
1-Octadecanol
112-92-5

Species/strain/system
Exposure Period::

Golden Orf (Leuciscus idus)
96 h

IRPTC Data Profile

Aquatic Acute Toxicity

57

Test Results
Organism Medium

Spec.

FISH

FRESH

AQ

General Comments

:

Route

Lifestage Sex

Effect Effect Comments

LC50 LC0 >10000 and LC50 >10000 mg/l.
(Purity of test substance questionable)
No further details were provided. The stated concentration exceeds theestimated water solubility of the substance by a factor of about 50 million.
(Water solubility = 2.05E-04 (calculated)). It is possible that the actual
substance tested was not pure 1-octadecanol, but a commercial mixture also
containing other alcohols.

References
Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 14, (1993)

IRPTC Data Profile

Aquatic Toxicity

58

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

AQUATIC TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium
ALGAE

AQ

Specification

Route

Lifestage Sex Number exposed Number controls

FRESH

Species/strain/system

Green algae (Scenedesmus subspicatus):

Test Method and Conditions
Test method
description

DIN 38412 part 9. (Approximates OECD Guideline 201). GLP: yes.

:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

EC10
Effect concentration EC10 = 21 mg/l
EC50
EC50 = 240 mg/l

References
Primary Reference:

HKAVT*
Algenzellvermehrungshemmtest nach (Cell Inhibition Test on Algae),
RE920040(9), (1992)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 13, (1993)

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

AQUATIC TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium

Specification

CRUS

FRESH

AQ

Species/strain/system

IRPTC Data Profile

:

Route

Lifestage Sex Number exposed Number controls

Water flea (Daphnia magna)

Aquatic Toxicity

59

Test Method and Conditions
Test method
description:

DIN 38412 part 2, corresponds approximately with OECD Guideline 202 part
1. No information given regarding the use of solvents or emulsifiers, the test
substance apparently having been added directly.

:
:
:
:

ACUTE
48 h
980-2900 mg/l
Doses of 1700mg/l were also tested.

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

EC0
Effect concentration EC0 = 980mg/l for 48h.
EC50
EC50 = 1700 mg/l for 48h.
EC100
EC100 = 2900 mg/l for 48h.
LOEC
The concentration of test substance producing any effect are about 1000000 times the water solubility (watersolubility = 1.1E-3mg/l)

References
Primary Reference:

HKBAD*
Bestimmung der Akuten Daphientoxizitat von Octadecanol im Daphnietest
nach DIN 38412 (Test of Octadecanol on Acute Toxicity to Daphnia according
to DIN 38412), 11 RE920029, (1992)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 12, (1993)

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

AQUATIC TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium

Specification

CRUS

FRESH

AQ

Species/strain/system

:

Route

Lifestage Sex Number exposed Number controls

Water flea (Daphnia magna)

IRPTC Data Profile

Aquatic Toxicity

60

Test SubstancePurity Grade:98%

Test Method and Conditions
Test method
description:

OECD Guidelines 202, part 2. Static test. GLP: yes. Octadecanol was added
directly without using solvents or emulsifier. Observations made with regard to
reproduction rate, mortality and time of first appearance of decendants.

:
:

LONG
21 d

Exposure
Exposure Type
Exposure Period

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NOEC
No observed effect concentration NOEC is approx. 100 times the water solubility = (1,1 E-3mg/l). NOEC =0.98 mg/l
No details were given about abnormal behaviour of daphnia (surface floating
General Comments:etc.).

References
Primary Reference:

HKBCD*
Bestimmung der Chronischen Daphnientoxizitat von Octadecanol im
Verlanerten Daphnientest (Prolonged Test on Chronic Toxicity of Octadecanol
to Daphnia), 920096, (1992)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 13, (1993)

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

AQUATIC TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium

Specification

FISH

ESTUA

AQ

Species/strain/system

:

Route

48
Rainbow trout (Oncorhynchus mykiss) weight: 30-40g

Test Method and Conditions
Test method
description

IRPTC Data Profile:

Lifestage Sex Number exposed Number controls

Static test

Aquatic Toxicity

61

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

:
:
:
:

ACUTE
96 h
1-1000 mg/l
Doses of 10 and 100mg/l were also tested

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No toxicity was observed. There were two deaths which were not dose-related

References
Primary Reference:

BFPIAB
Gorin, J. et al. Bulletin Francais de Piscisculture, 277, 163-185, (1980)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1993)

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

AQUATIC TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium

Specification

FISH

ESTUA

AQ

Species/strain/system

Route

Lifestage Sex Number exposed Number controls:

Rainbow trout (Oncorhynchus mykiss):::

20-40 mo
1-1000 mg/l
Doses of 10 and 100mg/l were also tested for fertilizing ability of sperm of
rainbow trout

Exposure
Exposure Period
Dose / Concentration
Exposure comments

IRPTC Data Profile

Aquatic Toxicity

62

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------RESP
At concentration of 1000mg/l (reported as ppm), a statistically significant drop in oxygeno-dependence leveloccurred both during the exposure period and after 2h recuperation in pure water.
METAB
NEF
Concentrations of 2-3mg/l (reported as ppm) seemed to have no effect on the rest of the metabolism.
EGG
REPRO
The fertility of eggs was significantly reduced (p<0.01) following 40 minutes exposure to 100mg/l.
SPERM
REPRO
Induced significant drop in fertilizing ability of sperm following exposure for 20 or 40 minutes andconcentrations of 1, 10, 100 or 1000mg/l.

References
Primary Reference:

BFPIAB
Billard, R. Bulletin Francais de Piscisculture, 271, 3-8, (1978)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, 10, (1993)

IRPTC Data Profile

Terrestrial Toxicity

63

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERRESTRIAL TOXICITY
1-Octadecanol
112-92-5
LAB

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

BACT

Species/strain/system:

Bacteria (Pseudumonas putida):

Lorol C18

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description:

Oxygen consumption test

:

ACUTE

Exposure
Exposure Type

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------

EC50
Effect concentration EC0 > 100 mg/l

References
Primary Reference:

HKDBA*
Datenblatt fur Altstoffe (Datasheet for Existing Chemical (1-Octadecanol)), 1,
2, (1988)

Secondary Reference:!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1993)

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64

Substance
Chemical Name
Reported Name
CAS Number:::

stearyl alcohol
112-92-5

Area Type Subject

Spec.

Description

Level / Summary Information :

CSK

-

PRMT
MXL

COMPONENT OF PLASTIC PRODUCTS PERMITTED FOR CONTACT WITH FOOD.
MAXIMUM LIMIT FOR THE PLASTIC MATERIALS: 20MG/G.
Title : DIRECTIVE NO.49 ON HYGIENIC REQUIREMENTS ON PLASTICS AND PLASTICGOODS COMING IN CONTACT WITH FOODSTUFFS

REG

FOOD
GOODS

Reference:

HPMZC*, 42, 1978

Effective Date :1JUL1978HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

Last Amendment :Entry / Update :DEC1991

Substance
Chemical Name
Reported Name
CAS Number:::

1-OCTADECANOL
112-92-5

Area Type Subject

Spec.

Description

Level / Summary Information :

DEU

INDST

CLASS
RQR

SATURATED FATTY ALCOHOLS WITH AN EVEN- NUMBERED C CHAIN, C NUMBER >=12, AND A TERMINAL OH GROUP ARE CLASSIFIED AS IN GENERAL NOT HAZARDOUS
TO WATER (WATER-HAZARD CLASS: WGK 0). (THE DIFFERENT CLASSES ARE: WGK 3 =VERY HAZARDOUS; WGK 2 = HAZARDOUS; WGK 1 = SLIGHTLY HAZARDOUS; WGK 0 =IN GENERAL NOT HAZARDOUS.) THE CLASSIFICATION FORMS THE BASIS FOR
WATER-PROTECTION REQUIREMENTS FOR INDUSTRIAL PLANTS IN WHICH WATERHAZARDOUS SUBSTANCES ARE HANDLED.
Title : ADMINISTRATIVE RULES CONCERNING WATER- HAZARDOUS SUBSTANCES(VERWALTUNGSVORSCHRIFT WASSERGEFAEHRDENDE STOFFE)

REC

AQ
USE

Reference:

GMSMA6, 8, 114, 1990

Effective Date :Gemeinsames Ministerialblatt. Joint Ministerial Papers

Last Amendment :Entry / Update :DEC1991

Substance
Chemical Name
Reported Name
CAS Number:::

stearyl alcohol
112-92-5

Area Type Subject

Spec.

Description

Level / Summary Information :

GBR

MARIN
MARIN
EMI

RQR
RQR
RQR

CLASSIFIED AS A NON-POLLUTING LIQUID SUBSTANCE. DOCUMENTARY EVIDENCE
OF ASSESSMENT AND APPROVAL REQUIRED BY A CARRIER. DISCHARGE INTO THE
SEA IS NOT PROHIBITED.
Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION BY NOXIOUS LIQUIDSUBSTANCES IN BULK) REGULATIONS 1987, SCHEDULE 2

REG

TRNSP
AQ
AQ

Reference:

GBRSI*, 551, 15, 1987

Effective Date :06APR1987

Entry / Update :1992

STATUTORY INSTRUMENTS

Last Amendment :GBRSI*, 2604, 2, 1990
STATUTORY INSTRUMENTS

IRPTC Data Profile

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65

Substance
Chemical Name
Reported Name
CAS Number:::

stearyl alcohol
112-92-5

Area Type Subject

Spec.

Description

Level / Summary Information :

USA

ADDIT
ADDIT
ADDIT

RSTR
RSTR
GL
RSTR

; SUMMARY - THIS SUBSTANCE INCLUDED ON A LIST OF SUBSTANCES USED TO
PREPARE BASE SHEET OR COATING SUBSTANCES FOR CELLOPHANE MUST BE OF A
GRADE OF PURITY SUITABLE FOR USE IN FOOD PACKAGING TO IMPART THE
DESIRED TECHNOLOGICAL PROPERTIES. ACRYLONITRILE COPOLYMER SUBSTANCES MUST ABIDE UNDER THE CONDITIONS GIVEN IN 21 CFR 180.22 1988.
Title : INDIRECT FOOD ADDITIVES; POLYMERS-CELLOPHANE.

REG

FOOD
PACK
MANUF
USE

Reference:

FEREAC, 42, 14572, 1977

Effective Date :1977

Entry / Update :NOV1991

Federal Register

Last Amendment :CFRUS*, 21, 177, 1200, 1988
Code of Federal Regulations

Substance
Chemical Name
Reported Name
CAS Number:::

1-OCTADECANOL
112-92-5

Area Type Subject

Spec.

Description

Level / Summary Information :

EEC

-

RQR
MXL
RSTR

THE SUBSTANCE MAY BE USED FOR THE MANUFACTURE OF REGENERATEDCELLULOSE FILM WHICH IS INTENDED TO OR DOES COME INTO CONTACT WITHFOODSTUFFS. THE MAXIMUM QUANTITY OF THE SUM OF 1-HEXADECANOL AND 1OCTADECANOL: 2MG/DM2 ON THE SIDE IN CONTACT WITH FOODSTUFFS.
Title : COUNCIL DIRECTIVE OF 25 APRIL 1983 ON THE APPROXIMATION OF THE
LAWS OF THE MEMBER STATES RELATING TO MATERIALS AND ARTICLESMADE OF REGENERATED CELLULOSE FILM INTENDED TO COME INTOCONTACT WITH FOODSTUFFS. (83/229/EEC).

REG

FOOD
FOOD
FOOD

Reference:OJEC**, L123, 31, 1983

Effective Date :01APR1987

Official Journal of the European Communities

Last Amendment :OJEC**, L228, 32, 1986

Entry / Update :OCT1987

Official Journal of the European Communities

IRPTC Data Profile