Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 402 (1987) EEC Directive 84/449 (1984) - Annex V - Method B3 EPA n° 798.1100 (1990) MAFF n° 4200 (1985)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
other: Sprague-Dawley rat

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Sterile Codex liquid paraffin
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
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:
Signs of toxicity related to dose levels:
None
Gross pathology:
Effects on organs:
None
Other findings:
Signs of toxicity (local):
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was not acutely toxic to Crl CDBR rats (LD50 > 5000 mg/kg) in a EU B.1 test conducted under GLP. The test result is considered as valid.
Executive summary:

The test substance was not acutely toxic to Sprague-Dawley rats (LD50 > 2000 mg/kg, dermally) in an OECD 402 and EU B.3 test conducted under GLP. The test result is considered as valid.