Registration Dossier
Registration Dossier
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EC number: 291-350-5 | CAS number: 90387-74-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed in 1998.
Test material
- Reference substance name:
- Glycine, N-coco acyl derivs., sodium salts
- EC Number:
- 291-350-5
- EC Name:
- Glycine, N-coco acyl derivs., sodium salts
- Cas Number:
- 90387-74-9
- Molecular formula:
- Molecular formula for this UVCB is not available.
- IUPAC Name:
- Glycine, N-coco acyl derivs., sodium salts
Constituent 1
- Specific details on test material used for the study:
- Name: Sodium cocoyl glycinate (GCS-12)
Lot No.: 970925
Description: Clear liquid
Composition: 31.5% solution
Storage: Cool, dark place
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 50 female Hartley guinea pigs were purchased from Charles River Japan, Inc. After the one-week quarantine and acclimatization period, 45 guinea pigs that showed no abnormality were selected and assigned to the vehicle control group, the test article group or the positive control group.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5-10
- Details on study design:
- Induction:
Intradermal: 5% (concentration for induction was based on the concentration in final products)
Epidermal: 5%
Challenge:
Because no primary dermal irritation was observed with respect to the test item in a preliminary study, a 5% (w/w) solution of the test item was used in the challenge. - Challenge controls:
- vehicle controls
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No indications for a skin sensitizing potential in guinea pigs
- Executive summary:
A skin sensitization study was conducted in guinea pigs using the maximization method. Distilled water for injection was used as a vehicle control, and 2,4-dinitrochlorobenzene was used as a positive control. No change was observed on the skin of the animals in the test item group following challenge, while skin reactions were observed in all animals of the positive control group.
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