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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed pre-GLP and no guideline is mentioned. Very limited data is provided on the methods and results, only a 1 page summary. No data on test substance composition or purity. Full evaluation of the validity of this study is not possible.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The test material was applied to the backs in appropriate doses and the site of application was covered with gauze bandaging and occluded with Saran Wrap.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2325 to 2960 grams
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: The site of application was covered with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Constant volume or concentration used: no data
- For solids, paste formed: no data

Duration of exposure:
24 hours
Doses:
1000, 2000, 4000, 8000 mg/kg bw
No. of animals per sex per dose:
1
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality on a daily basis, no data on body weight.
- Necropsy of survivors performed: no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 8 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute dermal toxicity in male and female albino rabbits would be greater than 8000 mg/kg bw.
Executive summary:

Eight New Zealand White rabbits, equally divided as to sex, weighing 2325 to 2960 grams were exposed. The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The test material was applied, as received, to the backs in doses of 1000, 2000, 4000, 8000 mg/kg bw. The site of application was covered with gauze bandaging and occluded with Saran Wrap.

The rabbits were observed for death at 24 hours and daily thereafter for a total of 14 days. None of the animals died, no other effects reported. The acute dermal toxicity in male and female albino rabbits would be greater than 8000 mg/kg bw.