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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (only females tested in the limit test, application on abraded skin should not be used according to OECD guideline 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
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): CH-216-110-1
- Related CAS number: 1318-02-1
- Chemical name: aluminosilicate
- Physical state: fine white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The skin of ten mature female rabbits (5 animals with abraded and 5 animals with intact skin) were treated with 2000 mg/kg test substance under occlusive dressing. After 24 hours, the wrapping was removed and the residue washed off.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The test sites were examined for erythema and edema and scores were recorded on a daily basis for 14 days. Body weight`s were recorded on day 0, 7 and 14. Gross necropsies were performed on day 14.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No adverse effects and no death were recorded.
Clinical signs:
No adverse effects and no death were recorded.
Body weight:
All rabbits maintained an acceptable body weight.
Gross pathology:
At sacrifice no abnormalities were noted which could be attributed to the treatment.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU