Registration Dossier
Registration Dossier
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EC number: 455-940-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented company data which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The test substance caused a positive reaction in 30% of the animals during the study using adjuvant method. In the case of adjuvant-type
test methods, a response of at least 30% of the animals is considered positive. So the test substance is classified as substance which
cause the sensitisation by the skin contact. - Executive summary:
The test substance is classified as substance which cause the sensitisation by the skin contact.
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