Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-367-7 | CAS number: 106-15-0
Endpoint summary
Administrative data
Description of key information
The results from the studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
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:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals. The study 2,3,4 are referred as study 1,2,3
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence based on structurally similar substances
- Justification for non-LLNA method:
- Currently no LLNA Study is available for assessment.
- Species:
- other: guinea pigs and humans
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 12%
- Day(s)/duration:
- 5 alternate-day 48-hour periods
- Adequacy of induction:
- other: for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each
- Day(s)/duration:
- every other day or 3 times weekly
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 12%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge.
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.05 ml of a freshly prepared 0.1% test chemical
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. not specified
2. 25 human volunteers
3. 2 male guinea pigs - Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
- Executive summary:
The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.
This estimated result is supported by a human maximization assay performed to determine the degree of dermal sensitivity caused by the test chemical. 12% of the test chemical was applied for 5 alternate-day 48-hour periods on the volar side of the arm of 25 participants after pretreatment for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge. There were no signs of sensitization for either the 48- or 72-hour challenge. Hence, the test chemical was considered to be not sensitizing to the skin of humans.
The above results are supported by the study conducted on 2 male white guinea pigs to determine the degree of dermal sensitivity caused by the test chemical. 0.1% Test material was dissolved in physiological saline. The test material was injected “intracutaneously” every other day or 3 times weekly until a total of 10 injections had been made. The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each. Two weeks following the tenth injection, a challenge injection was made using 0.05 ml of a freshly prepared 0.1% test chemical in physiological saline. Twenty-four hours after each injection, evaluations were made of the diameter, height, and color of skin reactions. No skin reactions were observed. Therefore, the test chemical was considered to be non-sensitizing to skin of guinea pigs.
The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.
This estimated result is supported by a human maximization assay performed to determine the degree of dermal sensitivity caused by the test chemical.
12% of the test chemical was applied for 5 alternate-day 48-hour periods on the volar side of the arm of 25 participants after pretreatment for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge. There were no signs of sensitization for either the 48- or 72-hour challenge.
Hence, the test chemical was considered to be not sensitizing to the skin of humans.
The above results are supported by the study conducted on 2 male white guinea pigs to determine the degree of dermal sensitivity caused by the test chemical. 0.1% Test material was dissolved in physiological saline. The test material was injected “intracutaneously” every other day or 3 times weekly until a total of 10 injections had been made. The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each. Two weeks following the tenth injection, a challenge injection was made using 0.05 ml of a freshly prepared 0.1% test chemical in physiological saline. Twenty-four hours after each injection, evaluations were made of the diameter, height, and color of skin reactions.
No skin reactions were observed. Therefore, the test chemical was considered to be non-sensitizing to skin of guinea pigs.
The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies indicate a possibility that the test chemical can be not sensitizing to skin.
Hence by applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.
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.
