Registration Dossier
Registration Dossier
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EC number: 485-350-6 | CAS number: 405095-33-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: ECHA diss. Dossier: GLP guideline study; documentation sufficient for assessment
Data source
Reference
- Reference Type:
- other: ECHA diss. Dossier
- Title:
- Skin sensitisation
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was not established when the skin sensitization test was conducted
Test material
- Reference substance name:
- (N-phenylcarbamimidoyl)ammonium carbonate
- EC Number:
- 613-106-2
- Cas Number:
- 6291-89-0
- IUPAC Name:
- (N-phenylcarbamimidoyl)ammonium carbonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 %, 0.1 mL per injection
- Route:
- other: epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %, 0.4 g paste per patch
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 %, 0.2 g paste per patch
- No. of animals per dose:
- test group: 20
control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- slight to well defined erythema, very slight edema
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- slight to well defined erythema, very slight edema
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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