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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 848-454-6 | CAS number: 1398610-04-2
Endpoint summary
Administrative data
Description of key information
Skin: Read across from Sarolaner step 2
DPRA: The mean of the SPCC and SPCL depletion was 1.3% and as a result the test item was considered to be negative in the DPRA and classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
The test item is classified as inconclusive in the KeratinoSensTM assay.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across based on structural similarity
- Justification for type of information:
- Read across from Sarolaner step 2
- Reason / purpose for cross-reference:
- read-across source
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- Imax [442D]
- Value:
- 1.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- Imax [442D]
- Value:
- 1.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: inconclusive
- Conclusions:
- The test item showed no toxicity (no IC30 and IC50 value) in both experiments. No
biologically relevant induction of the luciferase activity (no EC1.5 value) was measured at any
of the test concentrations in the first experiment. An induction of the luciferase activity (EC1.5
value of 0.82 μM) was measured in the second experiment as result of a fluctuation up to an
Imax of 1.60-fold. Since this was a clear outlier compared to the other dose levels in this
experiment and the results observed in the first experiment, it is likely the fluctuation was
caused by an incidental fluctuation and therefore considered not biologically relevant. The
maximum luciferase activity induction (Imax) was 1.30-fold and 1.60-fold in experiment 1 and
2 respectively. The test item is classified as inconclusive in the KeratinoSensTM assay since
negative results (<1.5-fold induction; excluding the outlier value in the second experiment)
were observed at test concentrations < 1000 μM with a cell viability of >70% compared to the
vehicle control. - Endpoint:
- skin sensitisation: in chemico
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across based on structural similarity
- Justification for type of information:
- Read across from Sarolaner step 2
- Reason / purpose for cross-reference:
- read-across source
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean cystein depletion
- Value:
- 0.7 %
- At concentration:
- 100 mM
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- mean lysine depletion
- Value:
- 1.9 %
- At concentration:
- 100 mM
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean of the SPCC and SPCL depletion was 1.3% and as a result the test item was considered to be negative in the DPRA and classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation in vitro, read across data:
DPRA, OECD 442C: negative;
KeratinoSens, OECD 442D: inconclusive.
Based on criteria in Table 3.4.2 of Regulation (EC) 1272/2008 and amendments, classification cannot
be concluded, further studies need to be performed to assess the skin sensitisation of the substance.
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.
