SRC TR

- 10

- 120

HPV4 CHEMICAL DATA A DEQUACY REVIEW

1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt , CAS No. 64665

- 57

- 2

Prepared by:

Justine Von Runnen

, Chris Janson , and Joan D. Garey

Chemical, Biological and Environmental Center

SRC, Inc

. 7502 Round Pond Road

North Syracuse, NY 13212

Contract No. EP

- W

- 09

- 027

Task FG007.0.009.002

Submitted to:

OPPT/RAD/HPVCB (7403M)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, D.C. 20460

Elizabeth Margosches

, Alternate Pr oject Officer

Meena Sonawane, Work Assignment Manager

David Brooks, Alternate Work Assignment Manager

July 9 , 2010HPV4 Chemical Data Adequacy Review

1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

July 2010

Submitted to:

High Production Volume Chemicals Branch

Risk Assessment Division

Off ice of Pollution Prevention and Toxics

Environmental Protection Agency

WAM: Meena Sonawan e

Alternate WAM: David Brooks

1200 Pennsylvania Avenue, NW

Washington, DC 20460

- 0001

Prepared By:

SRC , Inc.

Environmental Science Center

2451 Crystal Drive, Suite 804

Arlington, VA 22202Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

1 A. PREPARATION OF THE DATA ADEQUACY ASSESSMENTS

A

- 1. Source material used for assessment

For this unsponsored chemical, a comprehensive literature search was performed to

identify available toxicity data for the following SIDS endpoints:

Acute toxicity to fish

Acute toxicity to Daphnia

Toxicity to aquatic plants

Acute (oral, dermal, inhalation) toxicity

Repeated

- dose toxicity

Reproductive toxicity

D evelopmental toxicity

Gene mutation

Chromosomal aberrations

Studies relevant to non

- SIDS endpoints (e.g., eye and skin irritation; neurotoxicity) conducted

via oral, inhalation, or dermal routes were also identified through literature searching.

The foll owing sources were searched for toxicity data:

PubMed

- B ibliographic database that contains references to journal articles in the life

sciences with a concentration on biomedicine

T OXNET

- N ational L ibrary of M edicine databases on toxicology, hazardous c hemicals,

environmental health, and toxic releases; includes:

**•** TOXLINE with BIOSIS and NTIS ;

**•** Development and Reproductive Toxicology File (DART) ;

**•** Chemical Carcinogenesis Research Information System (CCRIS)

- Carcinogenicity and mutagenicity test results for over 8000

**•** chemicals) ;

**•** Hazardous Substances Data Bank (HSDB)

- Comprehensive, peer

reviewed toxicology data for about 5000 chemicals ;

**•** Genetic Toxicology Data Bank (GENE

- TOX)

- Peer

- reviewed genetic

toxicology test data for over 3000 chemicals.

TSCAT S

- U npublished technical reports submitted by industry to the EPA under the

Toxic Substances Control Act]

Registry of toxic effects of chemical substances (RTECs)

Environmental Fate Database (EFDB)

ECOTOX

- EPA’s peer

- reviewed ecotoxicology databaseDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

2 EP A’s Integrated Risk Information System (IRIS) website

Agency for Toxic Substances and Disease Registry (ATSDR) website

National Toxicology Program (NTP) website

International Program on Chemical Safety Concise International Chemical Assessment

Documents (IPCS INC HE M or CICADs)

European Chemical Substances Information System (ESIS)

- source of IUCLID Datasets

Any available IUCLID Datasets found through the ESIS website and robust summaries

submitted to EPA by former sponsors on the assigned chemicals w ere retrieved. Original

sources were obtained for any relevant toxicity data found for the assigned chemicals.

While IUCLID D ataset s sometimes contained studies of interest, certain study

descriptions contained insufficient detail to assess adequacy. In these cases, the primary source

of the study, if available and accessible, was obtain ed and review ed.

A

- 2. Evaluating data adequacy

Using standard OECD testing guidelines and professional judgment as guides, available

toxicity studies for the unsp onsored chemical were reviewed for adequacy. Summaries were

prepared for all relevant data found, even if little or no study detail was available. Each study

was summarized according to a standard format and assigned a Klimisch reliability code; all

study summaries for the chemical were combined into a single summary document. For studies

already assigned Klimisch codes (e.g., studies summarized in IUCLID datasets), an explanation

was provided if the reviewer’s assessment of data adequacy differed from th e pre

- assigned

Klimisch code. A table summarizing data availability/adequacy for each SIDS endpoint is

included at the end of the summary document.

B. SPECIFIC INFORMATION ON THE AVAILABLE TOXICITY DATA

The available data for each of the SIDS toxic ity endpoints are evaluated on the following

pages. Studies for a common endpoint are grouped together in the document and an endpoint

adequacy assessment is provided near the top of the first page of the summaries for that

endpoint. If the data availabl e for the endpoint is determined to be inadequate, a basis for that

conclusion is supplied.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

3 B

- 1. TOXICITY TO AQUATIC VERTEBRATES

Summary of endpoint: Adequate

Study 1: Acute toxicity to bluegill sunfish

Title: Acute Toxicity to Fish

This study is : Adequate Not Adequate

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Te st type: Static

GLP compliant?: Yes

Year study was performed: 1984

Test species: Bluegill sunfish ( Lepomis macrochirus )

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: 0, 15, 23, 34, 51, 77, 115 and 173 ppm

Tes t method/conditions remarks: Bluegill sunfish (initial bw = 5.0g) were acclimated for at

least 5 days. During the experiment, the fish were not fed. On Day 0, 10 fish were introduced

into test chambers containing nominal concentrations of 15, 23, 34, 51, 7 7, 115, and 173 ppm

test substance. Fish were observed daily for mortality and signs of intoxication.

Test Condition: Water temperature and dissolved Oxygen measured daily; pH measured at

beginning and end of study; hardness and alkalinity m easured at be ginning of study.

RESULTS

Endpoint value(s): The 96

- hour LC50 value for bluegill sunfish was > 173 ppm . The NOEC

was 34 ppm

.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

4 Results remarks:

Photoperiod = 16 hours light/day

Temperature: 15

- 18 degree C

pH: 7.1

- 7.8

Dissolved Oxygen: 5.4

- 8.4 mg/l

Hardness: 143

- 147 mg/l

Alkalinity: 54

- 55 mg/l

Aeration: none

Conc #fish Mortality/ signs of intoxication

24 h 48 h 72 h 96h

Control 20 0/0 0/0 0/0 0/0

15 ppm 10 0/0 0/0 0/0 0/0

23 ppm 10 0/0 0/0 0/0 0/0

34 ppm 10 0/0 0/0 0/0 0/0

51 ppm 10 0/7 0/4 0/3 0/0

77 ppm 10 1/9 1/9 1/9 1/9

115 ppm 10 0/10 0/10 0/10 0/10

173 ppm 10 0/10 0/10 0/10 0/10

Clinical signs were present at c oncentrations from 53 to 173. In general, the fish were either at

the surface or on the bottom and exhibited almost total inactivity, but were hyperreactive to

stimuli. Fish in the 51ppm group recovered by 96 hours, but none did in the higher

concentrations. One fish died in the 77ppm group, which appears to be an unusual sensitivity

since there were no deaths a t the two higher concentrations.

CONCLUSIONS

STUDY RELIABILITY

[1] Reliable without restrictions.

Reliability remarks: GLP study, Meets generally accepted scientific method and is described in

sufficient detail.

Flag: Critical study for SIDS endp oint

REFERENCE

SOCMA, Benzotriazole Coalition . IUCLID Data Set ID: 64665

- 57

- 2 (12/6/20 01). Study No

. 84

- 066

- 02. Mobay Chemical Corporation. August 3 , 1984.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

5 Study 2: Acute toxicity to rainbow trout

Title: Acute Toxicity to Fish

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test t ype: Not stated

GLP compliant?: Yes

Year study was performed: 1984

Test species: Rainbow trout ( Salmo gairdneri )

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: 0, 16.6, 19.9, 23.2, 27.4, 32.5, 38.4, and 53.8 ppm

Test method/conditions remarks: Rainbow trout (initial bw of 1.21

- 1.35g) were acclimated

for at least 5 days. During the experiment, the fish were not fed and the water was not aerated.

On Day 0, 10 fish were introduced into test chambers containing n ominal concentrations of 16.6,

19.9, 23.2, 27.4, 32.5, 38.4, and 53.8 ppm test substance. Fish were observed daily for mortality

and signs of intoxication. LC50 and 95% confidence limits were calculated according to Weil

CS. 1952. Biometrics. 8:249.

Test Condition: Water temperature and dissolved Oxygen measured daily; pH measured at

beginning and end of study; hardness and alkalinity measured at beginning of study.

RESULTS

Endpoint value(s): The 24

- , 48

- , 72

- , and 96

- hour LC50 value s for rainbow trout w ere > 53.8,

33 (31

- 35), 31 (29

- 32), and 25 (24

- 26) ppm, respectively.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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6 Results remarks:

Photoperiod = 16 hours light/day

Temperature: 9.0

- 12.3 degree C

pH: 7.1

- 8.6

Dissolved Oxygen: 3.4

- 18.8 mg/l

Hardness: 151

- 163 mg/l

Alkalinity: 56

- 70 mg/l

C onc #fish Mortality/ signs of intoxication

24h 48h 72h 96h

Control 20 0/0 0/0 0/0 0/0

16.6 ppm 10 0/0 0/0 0/0 0/0

19.9 ppm 10 0/0 0/ 1 0/4 0/4 *

23.2 ppm 10 0/0 0/ 1 0 1/9* 1/9 *

27.4 ppm 10 0/2 0/10* 0/10* 10/

- *

32.5 ppm 10 0/10 9/1* 9/1* 9/1 *

38 .4 ppm 10 0/ 9 5/5* 9/1* 10/

-

53.8 ppm 10 0/10 10/

- * 10/

- 10/

- * mortality values used to calculate the LC50.

CONCLUSIONS

STUDY RELIABILITY

[1] Reliable without restrictions.

Reliability remarks: GLP study, Meets generally accepted scientific method and is described in

sufficient detail.

Flag: Critical study for SIDS endpoint

REFERENCE

SOCMA, Benzotriazole Coalition. IUCLID Data Set ID: 64665

- 57

- 2 (12/6/2001). Study No.

84

- 066

- 01. Mobay Chemic al Corporation. June 15, 1984.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

7 Study 3: Acute t oxicity to zebrafish

Title: Acute Toxicity to Fish

This study is: Adequate Not Adequate

This study was considered inadequate due to missing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazo le, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Zebra fi sh ( Brachydanio rerio )

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 96

- hour LC 0 and LC 50 value s for zebra fish w ere 100 and 122 mg/L,

respectively.

CONCLUSIONS

STUDY RELIABILITY

[4] Not assignableDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

8 REFERENCE

Safety Data Sheet Bayer AG, 09.02.1999Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

9 Study 4: Acute toxicity to bluegill sunfish

Title: Acute Toxicity to Fish

This study is: Adequate Not Adequate

This study was considered inadequate due to missing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METH OD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Bluegill sunfish ( Lepomis macrochirus)

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concen trations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value: The 96

- hour LC50 value for bluegill sunfish was 191.2 mg/L.

CONCLUSIONS

STUDY RELIABILITY

[4] Not assignableDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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10 REFERENCE

PMC Specialties Group, Inc., MS DS 01/29/97Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

11 Study 5: Acute toxicity to rainbow trout

Title: Acute Toxicity to Fish

This study is: Adequate Not Adequate

This study was considered inadequate due to missing critical study information.

TEST SUBSTANC E

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Rainbow trout ( Salmo gairdneri )

Analytical monitoring: Not stated

Exposure duration: 96 hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): The 96

- hour LC50 value f or rainbow trout was 23.7 mg/L

.

CONCLUSIONS

STUDY RELIABILITY

[4] Not assignableDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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12 REFERENCE

PMC Specialties Group, Inc., MSDS 01/29/97Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

13 B

- 2. T OXICITY TO AQUATIC INVERTEBRATES

Summary of endpoint: A dequate

Study 1: Acute toxicity to Daphnia

Ti tle: Acute t oxicity to Daphnia

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% aqueous solution of sodium tolyltri azole

METHOD

Method/guideline followed: O ther: according to TSCA Public Law 94

- 469 (1976) and USEPA

Registration of Pesticides guidelines Fed. Reg. 07/10/78:29696

- 29741(1978)

Test type: Static

GLP compliant?: Yes

Year study was performed: 1978

Test species: Daphnia magna (Crustacea)

Analytical monitoring: Not stated

Exposure duration: 48

- hours

Concentrations tested: 0, 100, 180, 320, 560 and 1000 mg/L

Test method/conditions remarks: Water temperature, pH, and dissolved Oxygen measured at

beginn ing and end of study; hardness and alkalinity measured at beginning of study.

RESULTS

Endpoint value(s): The 24

- and 48

- hour LC50 value s for daphnids were 440 (320

- 560) and 280

(180

- 560) mg/L

. The NOEC was 100 mg/L.

Results remarks:

Photoperiod = 16 hours light/day

Temperature: 20 degree CDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

14 pH: 8.3

- 8.8

Dissolved Oxygen: 7.4

- 8.1 mg/l

Hardness: 225

- 275 ppm

Alkalinity: 325

- 375 ppm

Conc Mortality/ total # Daphnia

24h 48h

C ontrol 0/20 0/20

100 mg/l 0/20 0/20

180 mg/l 0/20 0/20

320 mg/l 0/20 14/20

560 mg/l 19/20 20/20

1000 mg/l 20/20 20/20

Clinical signs present at 180 mg/l were erratic behavior; at 320 mg/l Daphnia were either at the

surface or on the bottom; and at 560 mg/l one exhibited loss of equilibrium.

CONCLUSIONS

STUDY REL IABILITY

[1] Reliable without restrictions.

Reliability remarks: GLP, National standards method

Flag: Critical study for SIDS endpoint

REFERENCE

Analytical Bio

- Chemistry Laboratories, Inc. Report #32028. August 24, 1984Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

15 Study 2: Acute toxicity to Daphnia

Title: Acute toxicity to Daphnia

This study is: Adequate Not Adequate

This study was considered inadequate due to missing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5 )

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

METHOD

Method/guideline followed: Not stated

Test type: Not stated

GLP compliant?: Not stated

Year study was performed: Not stated

Test species: Daphnia magna (Crustacea)

Analytical monitoring: Not s tated

Exposure duration: 48

- hours

Concentrations tested: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value: The 48

- hour L C50 value for daphnids was 245.7 mg/L.

Results remarks: Not stated

CONCLUSIONS

STUDY RELIABILITY

[4] Not assignable.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

16 REFERENCE

PMC Specialties Group, Inc., MSDS 01/29/97Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

17 B

- 3. TOXICITY TO AQUATIC PLANTS

Summary of endpoint: Adequate

Study 1: Toxicity to green algae

Title: Toxicity to green algae

This study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remark s: 50% aqueous solution of sodium tolyltriazole

METHOD

Method/guideline followed: Not stated

Test type: Growth rate

GLP compliant?: Yes

Year study was performed: Not stated

Test species: Green algae ( Selenastrum capricornutum )

Analytical monitoring: Not stated

Exposure duration: 96

- hours

Concentrations tested: 0, 10, 30, 90, 270, and 810 mg/l (nominal co ncentrations)

Test method/conditions remarks: Selenastrum capricornutum (2x10 e4 cells/ml) were

exposed to test solutions of 0, 10, 30, 90, 270, and 810 mg/l (nominal concentrations) for four

days and observed during a four day withdrawal period. Growt h was monitored by cell counts

and estimated biomass.

Comparison of cell numbers and biomass during exposure and withdrawal were made using

Duncan's multiple range test with alpha = 0.05. Dose

- response analysis was done by probit

method using log nominal concentrations. Biomass was estimated as: biomass (mg) = # cells x

cell volume x 3.6 x 10 e

- 7.

T est condition: The cultures were kept at 26

- 27 degree C with 400 +/

- 40 footcandles continuous

cool

- white fluorescent illumination and were continually oscill ated on a platform at 100 rpm.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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18 Each concentr ation was tested in triplicate.

RESULTS

Endpoint value(s):

Growth EC50 (96hr) = 26.2 ppm (16.6

- 36.7)

Biomass EC50 (96hr) = 32.0 ppm (4.1

- 78.7)

NOEC = 100 ppm

Lowest algastatic concentration = 270 ppm

N o level tested was algacidal.

CONCLUSIONS

STUDY RELIABILITY

[1] Reliable without restrictions.

Reliability remarks: GLP study, Meets generally accepted scientific method and is described in

sufficient detail.

Flag: Critical study for SIDS endpoint

REFERENCE

Study No. 84

- 060

- 02. Mobay Chemical Corporation. August 2, 1984.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

19 B

- 4. ACUTE TOXICITY

Summary of endpoint : Adequate

Study 1: Acute oral toxicity gavage study in rats

Title: Acute oral toxicity in Wistar rats

The study is: Adequate Not Adequate

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test type: LD50

GL P compliant?: No data

Year study performed: 1983

Test species: Wistar rats

Number of animals/sex/dose: 5 /sex/dose

Route of administration: Oral gavage

Vehicle: Not data

Doses/concentrations tested: 1.0, 1.3, 1.6, 1.8, 2.5, 2.8 ml/kg

- bw

Statistical methods used: Not stated

Test method/conditions remarks: 5 rats/sex/dose, 5 doses: 1.0, 1.3, 1.6, 1.8, 2.5, 2.8 ml/kg

bw, given by gavage, observation time: 14 d, pathologic examination of rats that died during

observation time and of the survivors aft er termination.

RESULTS

Endpoint value: LD50 = 1.66 ml/kg

- bw (ca. 1980 mg/kg

- bw)Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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20 Results remarks: S igns of intoxication: reduced general condition, prone position, rough fur,

sedation. Pathologic examination: decedents: corrosion o f the gastric mucou s membranes;

survivors: no findings.

CONCLUSIONS

STUDY RELIABILITY

[2] Reliable with restrictions

Reliability remarks: Meets generally accepted scientific method and is described in sufficient

detail.

Flag: Critical study for SIDS endpoint

REFEREN CE

Bayer AG data, E. Löser: Untersuchungen zur akuten oralen Toxizität an männlichen und

weiblichen Ratten, June 1983.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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21 Study 2: Acute oral toxicity gavage study in male rats

Title: Acute oral toxicity in the male rat

The study is: A dequate Not Adequate

This study was considered inadequate due to miss ing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test type: LD50

GLP compliant?: Not stated

Year study performed: Not stated

Test species: Rat

Number of animals/sex/dose: Not stated/ male

Route of administration: Oral gavage

Vehicle: N o data

D oses/concentrations tested: Not stated

Statistical methods used: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): LD50 = 920 mg/kg

- bw (ca.)

Results remarks: Not statedDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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22 CONCLUSIONS

STUDY RELIABILITY

[4] Not assigna ble.

REFERENCE

PMC Specialties Group, Inc., MSDS 01/29/97

Safety Data Sheet Bayer AG, 09.02.1999Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

23 Study 3: Acute oral toxicity gavage study in female rats

Title: Acute oral toxicity in the fe male rat

The study is: Adequate Not Adequate

This study was considered inadequate due to miss ing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METH OD

Method/guideline followed: Not stated

Test type: LD50

GLP compliant?: Not stated

Year study performed: Not stated

Test species: Rat

Number of animals/sex/dose: Not stated/ female

Route of administration: Oral gavage

Vehicle: N o data

Doses/concentr ations tested: Not stated

Statistical methods used: Not stated

Test method/conditions remarks: Not stated

RESULTS

Endpoint value(s): LD50 = 640

– 735 mg/kg

- bw

Results remarks: Not statedDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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24 CONCLUSIONS

STUDY RELIABILITY

[4] Not assignable.

REFERE NCE

PMC Specialties Group, Inc., MSDS 01/29/97

Safety Data Sheet Bayer AG, 09.02.1999Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

25 Study 4: Acute dermal toxicity in rabbits

Title: Acute dermal t oxicity in the rabbit

The study is: Adequate Not Adequate

This study was considered inadequate due to miss ing critical study information.

TEST SUBSTANCE

Identity: 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% sodium tolyltriazole in water

METHOD

Method/guideline followed: Not stated

Test type: LD50

GLP compliant?: Not stated

Year study performed: Not stated

Test species: Rabbit

Number of animals/sex/dose: Not stated

Route of administration: Dermal

Vehicle: N o data

Doses/concentrations tested: Not stated

Statistical methods used: Not stated

Test method/conditions remarks: 24 hours of exposure.

RESULTS

Endpoint value(s): LD50 > 2000 mg/kg

- bw

Results remarks: R abbits exhibited no symptoms

.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

26 CONCLUSIONS

STUDY RELIABILITY

[4] Not assignable.

REFERENCE

Safety Data Sheet Bayer AG, 09.02.1999Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

27 B

- 5. SKIN IRRITATION STUDY

Study 1: Skin irritation study in rabbits

Title: Primary Skin Irritation Study in Rabbits: Albemarle BQ451

- 8 Biocide: Lab Project

Number: 7468: P326

TEST SUBSTANCE

Identity: 1H

- Benzotriazol e, 4(or 5)

- methyl

- , sodium salt, CAS No. 64665

- 57

- 2

Remarks: 50% aqueous solution of sodium tolyltriazole

METHOD

Method/guideline followed: OECD Guide

- line 404 "Acute Dermal Irritation/Corrosion"

Year: 1983

GLP (Y/N): No data

Species/strain: Rabbit

Sex (males/females/both): Not stated

Number of animals/sex/dose: 3 /sex not specified

Volume administered: Not stated

Test condition s :

Concentration: Undiluted

Exposure: Semiocclusive

Exposure Time: 4 hours

RESULTS

Result: Corrosive

CONCLUSIONS

RE LIABILITY CODE

[1] Reliable without restriction.

Reliability remarks: Guideline studyDraft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

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28 REFERENCES

Bayer AG data, Suberg H., Prüfung auf primär reizende/ätzende Wirkung an der Kaninchenhaut,

January, 1984.Draft HPV4 Chemical Data Adequacy Review CAS No. 646665

- 57

- 2

29 CAS No. 64665

- 57

- 2: Summary of Endpoints

Endpoint Study Information

Available Acceptable Data Gap

Aquatic Effects

Acute Toxicity to Fish Yes Yes No

Acute Toxicity to Daphnia Yes Yes No

Toxicity to Aquatic Plants Yes Yes No

Health Effects

Acute Toxicity Yes Yes No

Repeated

- Dose Toxicity No No Yes

Gene Mutation No No Yes

Chromosomal Aberrations No No Yes

Reproductive Toxicity No No Yes

Developmental Toxicity No No Yes