Registration Dossier
Registration Dossier
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EC number: 215-709-2 | CAS number: 1344-81-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
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:
- other: BUEHLER, E.V. 1965 Delayed contact Hypersensitivity in the Guinea Pig ( Arch. Dermatol. 91: 171-177
- Deviations:
- not applicable
- Principles of method if other than guideline:
- BUEHLER, E.V. 1965 Delayed contact Hypersensitivity in the Guinea Pig ( Arch. Dermatol. 91: 171-177)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This test was available in the SIEF.
Test material
- Reference substance name:
- Calcium sulfide (Ca(Sx))
- EC Number:
- 215-709-2
- EC Name:
- Calcium sulfide (Ca(Sx))
- Cas Number:
- 1344-81-6
- Molecular formula:
- CaSx (X=2,3,4,5,6,7)
- IUPAC Name:
- Calcium sulfide (Ca(Sx)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot number 910933, Lab number:8013
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 20% (5ml)
- Day(s)/duration:
- 2 weeks ( 3 times a week for 6 hours)
- Adequacy of induction:
- other: no irritation was noted at 20% concentration
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 ml of the 20% dilution
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 30 animals / sex : 10 test animals, 5 negative controls and 5 positive controls and 10 naive controls
- Details on study design:
- See it in the attachement page 36-38
- Challenge controls:
- Yes.
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml at 15% concentartion level
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Grade 1 irritation
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml at 20% concentration level
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Grade 1 irritation
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- It is classifed as skin sensitizer (H317).
- Executive summary:
It is classifed as skin sensitizer (H317).
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