Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study acceptable for assessment, basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
other: Acute Range Dermal Toxicity
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Remarks:
deionized
Doses:
2000 mg/kg bw
400 mg/kg bw
No. of animals per sex per dose:
2 males
2 females

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 - < 2 000 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Toxicity at a limit dose of 2000 mg/kg could not be determined due to the severity of irritation response seen at this dose level.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:

Based on the data the LD50 for the acute dermal toxicity of the TS is considered to be greater than 400 mg/kg bw in rats.
Further on it may be concluded that the LD50 is less than 2000 mg/kg bw. As the toxicity can not be determined at the limit dose of 2000 mg/kg bw
the TS should be classified as Xn; R 21 (harmful in contact with skin) for precautionary reasons.