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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:
key study
Study period:
From May 5, 1981 to May 21, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 85,772
- Lot/batch No.: S-13708-76

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Hewitt, N.J.
- Housing: Stainless steel cages with wire mesh bottoms
- Diet: Certified Rabbit Chow #5322 (Ralston Purina Company), ad libitum
- Water: Potable water, ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h fluorescent light/12 h dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal surface (back)
- Type of wrap if used: Occlusive wrap secured by bandaging and elastic tape


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2,000 mg/kg bw
- Concentration (if solution): Undiluted
- Constant volume or concentration used: Yes
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed twice daily for general condition, behavior, and signs of toxicity; Body weights were recorded on Days -1, 0, 1, 2, 3, 6, 10 and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One death occurred on Day 4
Clinical signs:
- Dermal irritation at the abraded sites; mean score of 3.9, maximal score on Day 14 with eschar formation
- No signs of systemic toxicity
Body weight:
No remarkable changes in the body weights
Gross pathology:
No significant pathological changes
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the test conditions, acute dermal LD50 of the test material in rabbits was determined to be > 2,000 mg/kg bw.

Executive summary:

A study was conducted to evaluate acute dermal toxicity of the test substance in rabbits. The study was performed according to a method similar or equivalent to OECD Guideline 402. The substance (2,000 mg/kg bw) was applied topically to the abraded skin of 5 male and female young adult rabbits via 24 h occlusive patches. All animals were observed twice daily throughout the 15 day study and all surviving animals were sacrificed. A gross post-mortem examination was performed and samples of the treated skin were retained. One death occurred on Day 4 but no specific signs of systemic toxicity were observed. Dermal irritation occurred at the abraded sites with mean score (Draize score) of 3.9 and maximal score observed on Day 14 with eschar formation. Under the study conditions, the acute dermal LD50 of the test substance in rabbits was determined to be >2,000 mg/kg bw (Chow, 1981).