4-methylanisole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-methylanisole

EC Number:

203-253-7

EC Name:

4-methylanisole

Cas Number:

104-93-8

Molecular formula:

C8H10O

IUPAC Name:

1-methoxy-4-methylbenzene

Details on test material:

- Name of test material (as cited in study report): p-Methylanisole
- Analytical purity: no data given

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

SD rats of both sex weiging 150-300 grams were individually housed and fed commercial diet and water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was administered as a 50 % (w/v or v/v) solution or suspension in corn oil as a single dose by gastric intubation and observed up to 14 days.

Doses:

Preliminary test: 5000 mg/kg bw
Main study: 1000-6810 mg/kg bw (6 dose groups). Not further specified.

No. of animals per sex per dose:

5 animals per dose in the main study, 2 animals in the preliminary test

Control animals:

not specified

Details on study design:

Male and female Sprague-Dawley rats weighing 150-130 grams were individually housed, fed and allowed water ad libitum. The animals were fasted over night and 2 animals per dose group were administered a single dose of the test substance at 5 ml/kg (5 g/kg) by gastric intubation. The test material was administered as a 50% (w/v or v/v) solution or suspension in corn oil. Following dosing, signs of toxicity and mortality were recorded at 1 and 4 hours and then once daily for 14 days. If no deaths occurred, an additional 8 rats were administered the same dose via the same route. The LD50 was determined if 1 or 2 animals in the first pair died within 48 hours, or if more than 2 of the total number of rats (n=10) died within the 14-day observation period. At the end of the study period, gross necropsy was performed on animals that survived as well as those that died during the study.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 920 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 510 - <= 2 450

Mortality:

At 5000 mg/kg bw (preliminary test) 2/2 animals died. At dlose level of 1000-6810 mg/kg, mortality was seen at 3160 mg/kg and higher.

Clinical signs:

other: Signs of toxicity included blood crust nose; diarrhea; depression; ataxia; hypopnea; lacrimation; salivation

Gross pathology:

Animals that died, necropsy revealed darkened lungs which appeared to be firm. There were no gross abnormalities in animals sacrificied at termination.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the experimental conditions of the test, the LD50 for acute toxicity after oral administration was reported as 1920 mg/kg bw in rats.