4-acetyl-2-methylbenzoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

03 January 2013 to 10 January 2013

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2013

Materials and methods

Principles of method if other than guideline:

A group of three fasted female rats was treated with the substance by oral gavage at a dose level of 300 mg/kg bw. Dosing was performed sequentially. The test substance was administered as a solution in 1% carboxymethyl cellulose. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

GLP compliance:

no

Test type:

acute toxic class method

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:

No details reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Test substance was administered as a solution in 1% carboxymethyl cellulose

Doses:

300 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

A group of three fasted female rats was treated with the test item at a dose level of 300 mg/kg bodyweight. Dosing was performed sequentially. The test item was administered orally as a solution in 1% carboxymethyl cellulose. Clinical signs and bodyweight development were monitored during the study over a period of 7 days. All animals were subjected to gross necropsy.

Statistics:

Not applied

Results and discussion

Preliminary study:

The oral LD50 value in female Wistar rats was estimated to be >300 mg/kg bw.

Mortality:

No mortality occurred.

Gross pathology:

No abnormalities detected

Any other information on results incl. tables

Development of bodyweight of test animals

Dose (mg/kg bw)	Animal number	Bodyweight (g), Day -1	Bodyweight (g), Day 0	Bodyweight (g), Day 7	Bodyweight gain (g)
300	1-0	194	189	201	12
300	1-1	177	174	195	21
300	1-2	189	184	199	15

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The oral LD50 of the substance in female Wistar rats was estimated to be >300 mg/kg bw.

Executive summary:

In a preliminary acute oral toxicity test, a group of three fasted female Wistar rats was treated by oral gavage with the test item at a dose level of 300 mg/kg bodyweight. Dosing was performed sequentially. The test item was administered orally as a solution in 1% carboxymethyl cellulose. Clinical signs and bodyweight development were monitored during the study over a period of seven days. All animals were subjected to gross necropsy. No mortality or adverse effects were observed and no abnormalities were noted at necropsy.