4-methylanisole

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Reference 2

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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

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

Test type:

standard acute method

Limit test:

yes

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 240 cm2 (approximately 10% of body surface)
- Type of wrap if used: test material was delivered under a rubber sleeve which was covered with Webril padding
- Test site was clipped and left intact in half of the animals, while lightly abraded in the remaining animals
- Amount(s) applied: 5 ml/kg bw

Duration of exposure:

Twenty four hours following exposure local dermal reactions were scored according to the Draize method. Toxicity , dermal reactions and mortality were recorded for 14 days.

Doses:

5 ml/kg bw => 4850 mg/kg bw (calculated using density : 970 g/l)

No. of animals per sex per dose:

6 animals per dose (no further data)

Control animals:

not specified

Details on study design:

Male and female New Zealand Albino rabbits weighing 2.5- 3 kg were individually house, fed a commercial diet and allowed water ad libitum. The test material was used as it was received. Groups of 3-6 rabbits were used and test material was applied to the test site measuring 240 cm2. The test sight on half the animals was abraded while the other half were left intact. The test material was delivered under a rubber sleeve which was covered with Webril padding to form an occlusive dressing. Twenty four hours later, the binders were removed and local dermal reactions scored according to Draize, J.H., 1959. Observations for toxicity, dermal reactions and mortality were performed once daily for 14 days. Necropsy was performed on animals that died during the study and those which were killed at termination of the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 850 mg/kg bw

Remarks on result:

other: >5 ml/kg bw (calculation based on a density of 970 g/l)

Mortality:

No deaths occured, all animals survived.

Clinical signs:

other: Erythema score: 2-3 in 6/6 animals Edema score: 1-3 in 5/6 animals Scaling in 5/6 animals Eschar in 3/6 animals One animal showed apparent skin disease on lower trunk during days 9-12 According to the authors, no other effects were seen.

Gross pathology:

Necropsy showed no gross findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 for acute toxicity after dermal administration was > 5 ml/kg bw (4850 mg/kg bw) in rabbits and by consequence doesn't trigger any classification for this end-point.