Registration Dossier
Registration Dossier
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EC number: 264-561-5 | CAS number: 63910-74-7
Endpoint summary
Administrative data
Description of key information
Skin sensitisation
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on guinea pigs and humans to determine the potential of skin sensitization caused by the chemical. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
- Species:
- other: 2.guinea pig 3. human
- Strain:
- other: 2. Not specified 3. Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml of 0.1 % aqueous solution
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- other: WoE-2
- Route:
- other: No data available
- Adequacy of induction:
- other: WoE-3
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml of 0.1 % aqueous solution
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- other: WoE-2
- Route:
- other: No data available
- Adequacy of challenge:
- other: WoE-3
- No. of animals per dose:
- Not specified
- Details on study design:
- 2. A. INDUCTION EXPOSURE
- No. of exposures: 3 times/ day for 5 successive days
- Exposure period: not speccified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times a day
- Duration: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: not specified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution
- Evaluation (hr after challenge): not specified
OTHER: challenge treatment was provided 4 weeks after the induction
3. Not specified - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.1 ml of 0.1 % aqueous solution
- Clinical observations:
- No skin allergic reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Clinical observations:
- A 16-years period of use in cosmetics not a single case of allergy in humans.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
- Executive summary:
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
The skin sensitization potential of test chemical was evaluated using Guinea pig maximization test. The test chemical in induction treatment was subjected onto the skin of guinea pig by intracutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.
The above study was supported with another skin sensitization study of test chemical assessed in a 16 year period study. In this study, the cosmetic use of test chemical did not cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
The skin sensitization potential of test chemical was evaluated using Guinea pig maximization test. The test chemical in induction treatment was subjected onto the skin of guinea pig by intracutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.
The above study was supported with another skin sensitization study of test chemical assessed in a 16 year period study. In this study, the cosmetic use of test chemical did not cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
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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