Registration Dossier
Registration Dossier
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EC number: 700-205-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/04/1993
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Batch number: C2413/173/3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: 10% w/v intradermal followed 7 days later by 75% w/v epicutaneous
Challange: 10% or 25% w/v topically
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 10% w/v intradermal followed 7 days later by 75% w/v epicutaneous
Challange: 10% or 25% w/v topically
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- GR101030X produced a 0% (0/20) senistisation rate and was classified as non-sensitising to guinea pig skin.
- Executive summary:
The dermal sensitisation potential of GE101030X was evaluated in the guinea pig using the Magnusson & Kligman Maximisation test. Twenty test and 10 control animals were used in the main study and based upon the results of sighting tests the following test concentrations were chosen: Intradermal induction 10% w/v in distilled water, Topical Induction: 75% w/v in distilled water, Topical challenge 10% and 25% w/v in distilled water. The test material produced a 0% (o/20) senitisation rate and was classified as a non-senitiser to gunea-pig skin.
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