Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Read-cross with the final product
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated patch test method (Marzulli & Maibach method)
- Principles of method if other than guideline:
- The repeated patch test method (Marzulli & Maibach method) is recognized as a predictive test for the determination of the dermal irritation and sensitization potential of products applied on skin.
The study was done in three phases:
- Induction phase: patches were applied to the same site on Monday, Wednesday and Friday for a three-week period. The test material was applied under an occlusive patch to the upper back and allowed to remain in direct skin contact for a period of 48 hours.
- Rest period: no product application during two weeks.
- Challenge phase: the challenge patches were applied to the previously treated sites on the back (homolateral) and to newly defined sites, previously unexposed (controlateral). After 48 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were again evaluated at 96 hours. - GLP compliance:
- not specified
- Remarks:
- Certified GCP (Good Clinical Practice)
- Type of study:
- other: Patch test
Test material
- Reference substance name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: induction phase, rest period, challenge phase
- Group:
- test chemical
- Dose level:
- pure product
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The evaluations assessed 48 hours and 96 hours after application of the patches revealed the following results:
| KOM 02180 | T 48 hours | T 96 hours |
| Induction site result (H) | 0 | 0 |
| Virgin site result (C) | 0 | 0 |
Under these study conditions, the product KOM 02180 demonstrated no potential for dermal sensitization.
No significant reaction occurred during both induction and challenge phases. The product KOM 02180 can be considered hypoallergenic.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on results obtained during both induction and challenge phases, the product KOM 02180 can be considered hypoallergenic (no potential for dermal sensitization).
- Executive summary:
The aim of this study was to determine the hypoallergenicity of the product KOM 02180 by evaluation of its irritating and sensitizing potential according to the Marzulli-Maibach method.
The study was done in three phases:
- Induction phase: patches were applied to the same site on Monday, Wednesday and Friday for a three-week period. The test material was applied under an occlusive patch to the upper back and allowed to remain in direct skin contact for a period of 48 hours.
- Rest period: no product application during two weeks.
- Challenge phase: the challenge patches were applied to the previously treated sites on the back (homolateral) and to newly defined sites, previously unexposed (controlateral). After 48 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were again evaluated at 96 hours.
The study was done on 52 healthy volunteers; two volunteers have discontinued the study. The completed study was done on 50 subjects, aged between 20 and 60 (average age: 41 +/- 2).
Based on results obtained during both induction and challenge phases, the product KOM 02180 can be considered hypoallergenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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