Registration Dossier
Registration Dossier
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EC number: 919-553-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- HRIPT
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HRIPT
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: HRIPT
Test material
- Reference substance name:
- 2-ketogluconic acid, calcium salt
- EC Number:
- 919-553-2
- Cas Number:
- 28098-92-2
- Molecular formula:
- C6H10O7.xCa
- IUPAC Name:
- 2-ketogluconic acid, calcium salt
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- male/female
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: HRIPT
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The results are not possible to fit the reporting template
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conformity with the methodology used to evaluate the potential for cutaneous irritation
and sensitization of the product Gel F Lote: 09-166 submitted by sponsor SOLIANCE, it can
be concluded that:
According to the test conditions and the results obtained, it could be concluded that the
product did not induce the process of cutaneous irritation and sensitization during the study
period.
This report is intended solely to internal use of the company SOLIANCE. No information in
this report can be made public in any means of communication without previous written
authorization by the author. - Executive summary:
In conformity with the methodology used to evaluate the potential for cutaneous irritation
and sensitization of the product Gel F Lote: 09-166 submitted by sponsor SOLIANCE, it can
be concluded that:
According to the test conditions and the results obtained, it could be concluded that the
product did not induce the process of cutaneous irritation and sensitization during the study
period.
This report is intended solely to internal use of the company SOLIANCE. No information in
this report can be made public in any means of communication without previous written
authorization by the author.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
