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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.