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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment: Non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on age, gender, weight and strain of rats and housing conditions

Data source

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

Materials and methods

Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimetol

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total no. of animals = 10
Control animals:
no
Details on study design:
- Animals were observed for mortality and clinical signs of toxicity for 14 days.
- Necropsy performed: Yes

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died
Clinical signs:
Skin irritation observed during acute dermal toxicity study:
slight redness - 2/10
moderate redness - 8/10
sllight edema - 1/10
moderate edema - 9/10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 for Dimetol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.