Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 219-989-7 | CAS number: 2592-95-2
Endpoint summary
Administrative data
Description of key information
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
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 based on various test chemicals
- Justification for type of information:
- Weight of evidence based on 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: Weight of evidence based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence based on various test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence based on various test chemicals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% of the test chemical in saline
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- diluted test material
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- diluted test material
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- diluted test material
- Day(s)/duration:
- 24-48 hours
- Adequacy of challenge:
- other: Re-chaleenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted test chemical
- Day(s)/duration:
- week 5
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 10% solution in petrolatum
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- other: Re-challenge
- No. of animals per dose:
- 1. 20 (10/sex)
2. 20 (10/sex) - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no signs of dermal sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
The skin sensitization study of the test chemical was assessed in guinea-pigs. Group of ten male and ten female guinea pigs were given several intra-dermal injections of 0.1% of the test chemical in saline together with an adjuvant. This was followed 2 weeks later by a challenge intra-dermal injection using the same concentration and, after a further 1 week, a 24-48- hour covered dermal application using a 30% solution in petroleum.
No skin reactions indicative of sensitisation were found. Thus, the the test chemical can be considered to be not a skin sensitizer.
This is supported by the results of a similar skin sensitisation study was performed on guinea pigs to determine the sensitisation potential of the test chemical.
The test was performed on 20 guinea pigs of both the sex using multiple subcutaneous injections of diluted test material for 3 weeks. After rest period of 14 days, on week 5 intradermal injections of test material were given as challenge dose. Re-challenge application given during week 7 using occlusive patch for 24hr duration in 10% solution in petrolatum. No skin reactions indicative of contact sensitisation were observed. Thus, it can be concluded that the test chemical was not a skin sensitizer.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
The skin sensitization study of the test chemical was assessed in guinea-pigs. Group of ten male and ten female guinea pigs were given several intra-dermal injections of 0.1% of the test chemical in saline together with an adjuvant. This was followed 2 weeks later by a challenge intra-dermal injection using the same concentration and, after a further 1 week, a 24-48- hour covered dermal application using a 30% solution in petroleum.
No skin reactions indicative of sensitisation were found. Thus, the the test chemical can be considered to be not a skin sensitizer.
This is supported by the results of a similar skin sensitisation study was performed on guinea pigs to determine the sensitisation potential of the test chemical.
The test was performed on 20 guinea pigs of both the sex using multiple subcutaneous injections of diluted test material for 3 weeks. After rest period of 14 days, on week 5 intradermal injections of test material were given as challenge dose. Re-challenge application given during week 7 using occlusive patch for 24hr duration in 10% solution in petrolatum. No skin reactions indicative of contact sensitisation were observed. Thus, it can be concluded that the test chemical was not a skin sensitizer.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.
Hence, by applying the weight of evidence approach,the test chemicalcan be considered to be not sensitizing to skin.
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.
