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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:
presumably 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methodical details are missing

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
3 male albino rabbits were used. The abdomen was closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.
GLP compliance:
not specified
Test type:
other: Data from a dermal skin irritation study are used, as 1 mL/kg bw (ca. 1000 mg/kg) was administered to rabbits
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
abdomen (intact skin)
Duration of exposure:
daily for 4 days
Doses:
1 mL/kg bw (ca. 1000 mg)
No. of animals per sex per dose:
3 m
Control animals:
no
Details on study design:
The abdomen was closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
> 1 000 mg/kg bw
Mortality:
No evidence
Clinical signs:
No evidence
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
ATBC did not induce toxic signs when applied to 3 rabbits over 4 consecutive days.
Executive summary:

In a skin irritation study, which likewise could be used as acute dermal toxicity study (ATBC was applied to rabbits over 4 days at a dosage of 1 mL/kg bw/d; ca. 1000 mg/kg), no signs of toxicity were noted. Therefore it can be concluded that ATBC is not toxic after dermal administration to rabbits at a daily dermal dose of ca. 1000 mg/kg.