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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:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 40 CFR, Part 798, Subpart B Section 798.1100, Toxic Substances Control Act, 1985
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): APD-1, 3
- Lot/batch No.: 227-124
- Analytical purity: No data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: test substance was moistened with water prior to application.
Details on dermal exposure:
TEST SITE
- % coverage: At least 10% of the body surface
- Type of wrap if used: The test substance was held in contact with the skin with porous gauze dressing and non-irritating tape. The animals were wrapped with Vetrap bandaging for the 24 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were rinsed with USP sterile water for injection
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: No. The test substance was moistened with water at the time of dosing.
Duration of exposure:
24 hours
Doses:
2000 mg/ kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs, but the frequency was not reported. The animals were weight at least before administration of the test substance and at the end of the observation period.
- 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 was no mortality during the study period.
Clinical signs:
None of the test animals exhibited clinical signs of toxicity during the course of the study.
Body weight:
All animals gained weight during the course of the study.
Gross pathology:
No lesions were observed during the pathological examination.
Other findings:
Nine out of ten animals exhibited slight to defined erythema. One rabbit also exhibited edema at the 24 hour scoring point. It is not reported whether the lesions were reversible.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified