Registration Dossier
Registration Dossier
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EC number: 306-361-3 | CAS number: 97158-31-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 May 1994 - 10 June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was unkown in 1994
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- intradermal injection at 5%w/w in water
- Day(s)/duration:
- once
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- topical application at 50%w/w in water
- Day(s)/duration:
- 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- topical challenge at 50, 25, 10, 5%w/w in water
- Day(s)/duration:
- 1
- Adequacy of induction:
- other: challenge
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- topical challenge at 50, 25, 10, 5%w/w in water
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 4 per challenge dose
- Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- Positive control experiment: Notox 108258 (January 1994) with Formaldehyd (37%): intradermal 0.38%w/w in water; epidermal 0.38%w/w in water; challenge 0.2% in water
Results and discussion
- Positive control results:
- maximum sensitisation rate: 70% in the experimental group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no treatment related adverse effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no treatment related adverse effects
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2% Formaldehyd 37%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- maximum sensitisation rate: 5% in the experimental group (50% challenge concentraion).
PR-1577 has weak sensitising properties in this test applying the rating of allergenicity described by Kligman AM (1966).
Based on the criteria of EEC Directive 91/325/EEC, Amendment to Annex VI of EEC DIrective 67/548/EEC PR-1577 need not be labelled as a skin sensitiser.
GHS/CLP criteria are not met.
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