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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 911-428-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Cross-reference
- Reason / purpose for cross-reference:
- assessment report
Data source
Materials and methods
Test material
- Reference substance name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
- EC Number:
- 911-428-0
- IUPAC Name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
- Test material form:
- solid: flakes
Constituent 1
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 25%
- Remarks on result:
- other: Montan wax, type E
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 50%
- Remarks on result:
- other: Montan wax, type E
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 100%
- Remarks on result:
- other: Montan wax, type E
- Parameter:
- EC3
- Test group / Remarks:
- could not be calculated
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a reliable study a member of the category of Montan waxes (an extract of Montan wax, type E (25-100%)) was not sensitising in a Local Lymph Node Assay in mice under the conditions of this study (extracted in acetone:olive oil (4:1) for 72 h at 37 °C).
- Executive summary:
The study used as source investigated the skin sensitising potential of a member from the category of Montan waxes.
The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in
section 13 or find a link in cross reference “assessment report”.
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.
