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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-057-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LLNA on analogue substance : not sensitising (OECD 429, GLP, K, rel.2)
GPMT : not sensitising (sim. OECD 406, rel.3)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A key study was identified (RCC, 2007, rel.2). This Local Lymph Node Assay was conducted according to the OECD test guideline No 429 and in compliance with GLP on an analogue substance.
Five groups each of four female mice were treated daily with the test substance at concentrations of 2.5 %, 5 %, 10 %, 25 % and 50 %(w/v) in propylene glycol by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four female mice was treated with the vehicle propylene glycol only.
The historical positive control, α-Hexylcinnamaldehyde was found to be a potential skin sensitizer in the LLNA tests and an EC3 value of 11.2 % was derived. The test system was therefore considered to be valid.
The Stimulation Index (S.I) of 1.2, 0.9, 1.0, 1.3 and 1.4 were determined with the test substance at concentrations of 2.5 %, 5 %, 10 %, 25 % and 50 % (w/v), respectively, in propylene glycol.
All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period. No abnormal findings were observed in the size or other physical features of the draining lymph nodes.
Under the test conditions, the test material is not classified as skin sensitiser.
An other study (Huntingdon, 1979) performed on the registered substance in rats was non-GLP and was of poor quality (Klimish score = 3) but supports the results of the key study.
CONCLUSION: Not sensitising
Moreover, in the HERA report on Esterquats of November 2009, the result of a GPMT performed by Unilever on Hamburg Ester Quat (HEQ), an other analogue of the registered substance, is "Not a sensitizer".
Reference:HERA (2009). Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products (HERA), Avenue Herrmann Debroux ISA, B-1160 Brussels Belgium. Edition 1.0 November 2009. Esterquats Human Health Risk Assessment Report. <http://www.heraproject.com/files/17-HH-HERA-EQ-HH-TM-finalDraft-24Nov%20web.pdf>.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available data, the substance is not classified as skin sensitizer according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
No data was available for respiratory sensitisation. However, this substance is not a skin sensitizer, therefore according to Figure R.7.3 -2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not considered as a respiratory sensitizer.
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.
