Octadecanedioic acid, 1,18-dimethyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 January 2012 to 01 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl 9-decenoate

EC Number:

662-772-0

Cas Number:

25601-41-6

Molecular formula:

C11H20O2

IUPAC Name:

methyl 9-decenoate

Details on test material:

- Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: Clear colourless liquid
- Purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage conditions: room temperature in the dark under nitrogen

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of 9-decenoic acid, methyl ester (9DAME) in the Wistar strain rat was found to be >2000 mg/kg bw.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item in the Wistar rat, according to OECD Guideline 402, in compliance with GLP. A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item it intact skin at a dose level of 2000 mg/kg bw. There were no mortalities or signs of systemic toxicity during the study. Very slight erythema was noted at the test sites of all males and one female. Small superficial scattered scabs were also noted at the test site of one male. There were no signs of dermal irritation noted in four females. Animals showed expected gains in bodyweight over the study period except for one female which had a slight bodyweight loss during the first week but expected gain in bodyweight during the second week. No abnormalities were noted at necropsy. The acute dermal LD50 of 9-decenoic acid, methyl ester in the Wistar strain rat was therefore estimated to be greater than 2000 mg/kg bw (Harlan Laboratories Ltd, 2012).