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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25th May 1993 to 8th June 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2518 to 2793 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 50-82 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 20 %
- Type of wrap if used: Doses were applied under gauze binders that were secured with tape. Collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with wet disposable paper towels moistened with mineral oil (USP).
- Time after start of exposure: At the end of the exposure period

TEST MATERIAL
- Amount(s) applied: 2.13 mL/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical effects at 1, 3 and 4 hours post dosing on day 0, thereafter animals were observed twice daily (morning and afternoon) for mortality and once daily for clinical observations for the rest of the 14 day observation period. Body weights were measured on days 0, 7 and 14. Dermal observations were performed 30-60 minutes after bandage removal and daily thereafter. The animals were shaved and days 3, 7, 10 and 14 to facilitate observations.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no unscheduled deaths during the study.
Clinical signs:
Vocalisation after handling was noted in one femal of day 2. One female had dried red material around the mouth on day 0 that was considered to be related to the restraining collar. There were no other clinical findings during the study.
Body weight:
There were no remarkable changes or differences in body weights during the study.
Gross pathology:
An accessory spleen was noted for two rabbits terminally necropsied. This is a common congenital abnormality. There were no other gross necropsy findings.
Other findings:
The test material induced moderate to severe erythema and oedema in all rabbits. All sites had desquamation initially on day 4-5. Nine rabbits were hypersensitive to site manipulation during the dirst week of the study. Eschar and subsequent exfoliation were present on six sites by day 7. Fissuring was noted sporadically during the first week of the study for six sites. All sites had very slight to slight erythema and/or oedema and desquamation at study termination (day 14). There were no other dermal findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was examined in male and female rabbits in a study conducted in accordance with OECD 402, EU Method B.3 and EPA OTS 798.1100. Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.