4-acetyl-2-methylbenzoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Principles of method if other than guideline:

A group of three female Wistar rats were given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 1000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study over a period of 8 days. All animals were subjected to gross necropsy.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-acetyl-2-methylbenzoic acid

EC Number:

856-079-4

Cas Number:

55860-35-0

Molecular formula:

C10H10O3

IUPAC Name:

4-acetyl-2-methylbenzoic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Not reported

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The substance was applied to the intact skin.

Duration of exposure:

24 hours

Doses:

1000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

A group of three female Wistar rats were given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 1000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study over a period of 8 days. All animals were subjected to gross necropsy.

Statistics:

Not applicable

Results and discussion

Preliminary study:

The dermal LD50 in female Wistar rats was estimated to be >1000 mg/kg bw.

Mortality:

No mortality occurred

Body weight:

lower than 10% body weight loss

Gross pathology:

No abnormalities detected

Other findings:

No signs of dermal irritation occurred. The scores for erythema, oedema and other local effects on skin were 'zero' at all time points for all three test animals over a period of 8 days.

Any other information on results incl. tables

Bodyweigt development of test animals

Dose (mg/kg bw)	Animal number	Bodyweight (g), Day 0	Bodyweight (g), Day 7	Bodyweight gain (g)
1000	1-0	227	221	-6
1000	1-1	226	227	1
1000	1-2	230	222	-8

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The dermal LD50 value in female Wistar rats was estimated to be >1000 mg/kg bw.

Executive summary:

In a preliminary acute dermal toxicity study, s group of three female Wistar rats were given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 1000 mg/kg bodyweight. Clinical signs, signs of dermal irritation and bodyweight development were monitored during the study over a period of eight days. All animals were subjected to gross necropsy. No mortality occurred, no clinical signs of toxicity and of dermal irritation occured and no abnormalities were observed at necropsy. There was a small effect on the bodyweight development, with a decrease in bodyweight of less than 10% in two animals, and only minor bodyweight gain in one animal.