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EC number: 500-295-0 | CAS number: 106233-09-4 1 - 2.5 moles ethoxylated
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for grouping of substances and read-across
There are no data available for the skin sensitising effects ofAlcohols, C16-18, ethoxylated, phosphates(CAS 106233-09-4). In order to fulfil the standard information requirements set out in Annex VIII in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity,Alcohols C16-18 (even numbered), ethoxylated (< 2.5 EO) (CAS 68439-49-6) is selected as source substance for assessment of skin sensitisation.
Skin sensitisation
Target substance (a)
Source substance(b)
CAS
106233-09-4
68439-49-6
Chemical name
Alcohols, C16-18, ethoxylated, phosphates
Alcohols C16-18 (even numbered), ethoxylated (< 2.5 EO)
MW
322.42 – 867.27 g/mol
242.5 – 402.7 g/mol
Skin sensitisation
RA:68439-49-6
Experimental result: not sensitising
(a) The substance subject to the REACh Phase-in registration deadline of 31 May 2013 is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font.
The read-across is mainly based on similar precursers/breakdown products of the target and the source substances. The available endpoint information is used to predict the skin sensitising potential forAlcohols, C16-18, ethoxylated, phosphates(CAS 106233-09-4).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
A skin sensitisationstudy conducted withAlcohols C16-18 (even numbered), ethoxylated (< 2.5 EO)(CAS 68439-49-6)was performed according to OECD Guideline 406 (Eisele, 1995). In this study 20 female guinea pigs were induced by an epicutaneous occlusive dressing with 100% test substance (in maize oil) for 6 h on Day 0, 7 and 14. Two weeks after the last induction animals were challenged by epicutaneous occlusive exposure for 6 h to 100% test substance (in maize oil). 24 and 48 h after patch removal the application site was assessed for signs of local irritation. No dermal reactions were observed in any test animal at any time point. In conclusion,Alcohols C16-18 (even numbered), ethoxylated (< 2.5 EO) is not sensitising to the skin under the described conditions.
QSAR calculations with the OECD toolbox revealed no protein binding alerts with OASIS v1.1 forAlcohols, C16-18, ethoxylated, phosphates.
In general, alcohol ethoxylates are not considered to be skin sensitisers (HERA, 2009). 37 studies were available (according to Magnusson-Kligman or Buehler) were no effects were observed indicating a skin sensitisation potential of the alcohol ethoxylates. One ambiguous study was available indicating a slight sensitising potential, taken into consideration that the observed reactions may have been confounded with irritating reactions.
Conclusion
Based on the available information on breakdown products ofAlcohols, C16-18, ethoxylated, phosphates and the information gained from reports and QSAR calculations onsulphates and phosphates of ethoxylated alcohols, no skin sensitising properties are expected forAlcohols, C16-18, ethoxylated, phosphates.
Migrated from Short description of key information:
Buehler test (similar to OECD 406, GLP, RL2): not sensitising to skin
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of Alcohols, C16 -18, ethoxylated, phosphates are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).
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.
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