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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
No data on the test method available.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
5.00 g/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10
Clinical signs:
none reported

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The dermal LD50 is > 5000 mg/kg bw and therefore, the substance does not need to be classified according to CLP regulation.
Executive summary:

In the current study a standard acute method was used to determine the acute dermal toxicity of the test item, however, no data are available concerning type and duration of dermal coverage. 10 animals were dosed once and observed for 14 days.

At a dose of 5.00 g/kg bw no animal died and no clinical signs were reported.

It can be concluded that the LD50 is > 5000 mg/kg bw as at this dose 0 out of 10 animals died. This is above the cutoff value of 2000 mg/kg bw of the CLP Regulation and therefore, the substance does not need to be classified.