Registration Dossier

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:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Paste with distilled water containing 0.5% carboxymethyl- cellulose and 0.1% polysorbate 80.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
no data
Body weight:
no data
Gross pathology:
Effects on organs:
No treatment-related gross pathological effects were noted.
Other findings:
Signs of toxicity (local):
No deaths. Dyspnoea (slight-moderate) together with exophthalmus, ruffled fur and ventral or curved body posture (all slight) were noted. Signs were seen from 1 hour post dose to day 12. No treatment-related cutaneous changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

The acute dermal toxicity of the test substance has been determined in a GLP test with rats according to "Annex V" in a limit test. The LD50 value was > 2000 mg/kg bw (male/female).