Chlorinated Fatty Acid Methyl Ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February 1987

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl tetradecanoate, chloro

Molecular formula:

C13H26Cl4COOCH3 and C13H25Cl5COOCH3 (primary isomers based on product weight of 35-40% Cl by weight)

IUPAC Name:

methyl tetradecanoate, chloro

Constituent 2

Reference substance name:

Methyl octadecanoate, chloro

Molecular formula:

C17H30Cl4COOCH3, C17H29Cl5COOCH3 , and C17H28Cl6COOCH3 (primary isomers based on 35-40% Cl by weight)

IUPAC Name:

Methyl octadecanoate, chloro

Constituent 3

Reference substance name:

Methyl hexadecanoate, chloro

Molecular formula:

C15H28Cl4COOCH3 and C15H27Cl5COOCH3 (primary isomers based on 35-40% Cl by weight)

IUPAC Name:

Methyl hexadecanoate, chloro

Test material form:

liquid

Details on test material:

This is a UVCB substance developed from the chlorination of fatty acid methyl esters.

Specific details on test material used for the study:

Batch A070806

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanRcc:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age when treated:
Males: 8 weeks
Females: 11 weeks

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

The test item was diluted in vehicle (Polyethylene glycol 300) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not required

Details on study design:

Five male and five female HanRcc:WIST (SPF) rats were treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None

Clinical signs:

None

Body weight:

Body weights were normal for the strain/sex/age of the test animals.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

All animals showed a slight erythema at removal of the dressing on test day 2. The erythema persisted in all five males up to test day 4 or 7. Slight crusts were present in three males from test day 5 or 7 and persisted until test day 8 or 10. One male showed additionally slight scaling from test day 5 to 8.

Applicant's summary and conclusion

Conclusions:

Based on the results of the study the acute dermal LD50 for C16 and C18 chlorinated methyl esters (DA 8506) is >2000 mg/kg bw.

Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with C16 and C18 chlorinated methyl esters (DA 8506) at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was

recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No clinical signs were noted. No macroscopic findings were observed at necropsy.

All animals showed a slight erythema at removal of the dressing on test day 2. The erythema persisted in all five males up to test day 4 or 7. Slight crusts were present in three males from test day 5 or 7 and persisted until test day 8 or 10. One male showed additionally slight scaling from test day 5 to 8.

Based on the results of the study the acute dermal LD50 is >2000 mg/kg bw.