m-toluic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987-02-24

Deviations:

yes

Remarks:

one sex only; one dose only instead of 3 doses; observation period lasted 7 d instead of 14 d; clinical signs were not reported (exception: skin reaction); gross pathology & body weight measurements were missing; housing conditions incompletely described

GLP compliance:

not specified

Remarks:

not specified in the study report

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

m-toluic acid

EC Number:

202-723-9

EC Name:

m-toluic acid

Cas Number:

99-04-7

Molecular formula:

C8H8O2

IUPAC Name:

m-toluic acid

Test material form:

solid: flakes

Details on test material:

- Appearance: light yellow flakes
- Molecular weight: 136.1
- Density: 1.04 g/cm³ (112 °C)
- Flash point: 147 °C
- Boiling point: 263 °C
- Melting point: 111.7 °C

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was finely pulverized in an agate mortar

Test animals

Species:

rabbit

Strain:

other: Japanese white Kbs:JW

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Weight at study initiation: 2.1 - 2.5 kg
- Diet (ad libitum): solid feed RC-4 (obtained from Oriental Yeast K.K)
- Water (ad libitum): tap water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 55 ± 6 %

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: on the day before the test, the hair on the back of the rabbits was removed with an electric clipper. The test item was applied within a circle of 3 cm. The test item was applied onto intact and abraded skin of each rabbit.
- Type of wrap if used: two layers of gauze patch fixed with Tegaderm (3M) and Ju Picot 5 (obtained from Tokyo Material Research Institute) were used to cover the area of exposure after test item application.

REMOVAL OF TEST SUBSTANCE
- Washing: the application site was cleaned with a gauze soaked in water after application.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1000 mg/animal (0.5 g test substance/intact skin area and 0.5 g test substance /abraded skin)

Duration of exposure:

24 hours

Doses:

1000 mg/animal (0.5 g test substance/intact skin area and 0.5 g test substance /abraded skin)

No. of animals per sex per dose:

6 male rabbits

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: 24, 48, 72 and 168 hours
The extent of erythema and oedema of the skin was evaluated according to the Draize scale.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male

Based on:

test mat.

Remarks on result:

other: see "Remarks"

Remarks:

After a test item application, all animals survived until the end of the observation period. Following the 24 hour exposure, three animals of the 6 treated animals (intact skin of one animal and abraded skin of two animals) displayed a mild erythema (grade 1) at the 24 hour observation (disappeared after 48 h). No further signs of erythema and/or oedema were observed during the observation period.

Mortality:

All animals survived until the end of the observation period.

Clinical signs:

Following the 24 hour exposure, three animals of the 6 treated animals (intact skin of one animal and abraded skin of two animals) displayed a mild erythema (grade 1) at the 24 hour observation (disappeared after 48 h). No further signs of erythema and/or oedema were observed during the observation period.

Body weight:

no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

After a test item application of 1000 mg/animal (0.5 g test substance/intact skin area and 0.5 g test substance /abraded skin), all animals survived until the end of the observation period. Following the 24 hour exposure, three animals of the 6 treated animals (intact skin of one animal and abraded skin of two animals) displayed a mild erythema (grade 1) at the 24 hour observation (disappeared after 48 h). No further signs of erythema and/or oedema were observed during the observation period.