Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Test type:
other: no data
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
Test material form:
not specified

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Duration of exposure:
24 h
Doses:
Male: 1333 mg/kg bw
Female: 1333 mg/kg bw
No. of animals per sex per dose:
Male: number of animals 5
Female: number of animals 5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 333 mg/kg bw
Based on:
not specified
Mortality:
Male: 1333 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1333 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Common symptoms in acute tests (piloerection, abnormal body position and dyspnea). All animals recovered within 2 days.
Gross pathology:
Effects on organs: none
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
LD50 >1333 mg/kg bw (maximum amount of test substance applicable)
Executive summary:

The acute dermal toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline 402 and EU methog B.3 in a limit test. The LD50 (24h) value was > 1333 mg/kg bw, the test substance did not cause mortality nor toxic effects under the conditions of the test. Due to the high viscosity, it was not possible to apply the test substance undiluted to the skin of the rats, only a threefold dilution did allow a quantitative application of the test article and in view of the maximum volume applicable (= ca. 4 mL/kg body weight) according to the OECD-Guideline, 1333 mg/kg bw was the maximum amount of test substance applicable.