Registration Dossier

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:

There is no skin sensitisation data available for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4. There is however data available for read across from another member of the primary fatty amine ethoxylates family , (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7. These two substances have similar carbon chain distributions and either corrosive or strong irritants to the skin, this makes it difficult to perform animal test for skin sensitisation. As this study is available it is not scientifically justified on animal welfare grounds to perform a study on this test substance

The potential of the test item CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

Based on preliminary testing, where only a dose of 0.1% of the test substance was well tollerated with acceptable effects at the injection site, this concentration was used for the intradermal induction the test item at the concentration of 0.1% in corn oil (treated group) or vehicle alone (control group), the test item at the concentration of 0.1% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated group) or vehicle at the concentration of 50% (w/v) in a mixture FCA/0.9% NaCl (50/50, v/v) (control group) were administered.

Then on day 8 the topical induction was the animals of the treated group received the test item at the concentration of 10% (w/w) in ethanol/water (80/20) to the same test site, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle under the same experimental conditions.

On day 22, all animals of both groups were challenged by a cutaneous application of the test item at the concentration of 1% (w/w) in acetone to the right flank. The test item was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.

As the doses used were selected based on the criteria in the OECD guideline the study is considered to be valid.

No systemic clinical signs and no deaths were noted during the study. No relevant cutaneous reactions were observed after the challenge application.

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, does not induce delayed contact hypersensitivity in guinea pigs.

Skin sensitisation potential is related to the reactivity of the substance with proteins. (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 contains a significant proportion of unsaturated C18 compared to 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4 which is completely saturated. Unsaturation of the molecule is associated with increased reactivity, therefore this read across is considered to be a worst case for the 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4 which supports this substnace being considered not to be a skin sensitiser.

Migrated from Short description of key information:

There is no skin sensitisation data available for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4.  There is however data available for read across from another member of the primary fatty amine ethoxylates family , (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 whch is equivalent to Bis(2-hydroxyethyl) oleyl amine CAS No 25307-17-9.

The potential of the test item CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and to OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996) guidelines to GLP.  CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, did not induce delayed contact hypersensitivity in guinea pigs.

Justification for selection of skin sensitisation endpoint:

There is no skin sensitisation data available for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30 – 4. There is however data available for read across from another member of the primary fatty amine ethoxylates family , (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7.  These two substances have similar carbon chain distributions and either corrosive or strong irritants to the skin this makes it difficult to perform animal test for skin sensitisation.  As this study is available it is not scientifically justified on animal welfare grounds to perform a study on this test substance

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no guidelines for an animal test for respiratory sensitisation, however in general respiratory sensitisers and also skin sensitisers. The lack of any indication of skin sensitisation in the OECD 406 GLP compliant study on CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser. This data is also considered applicable by read across to the similar chemical 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4

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Migrated from Short description of key information:

There are no guidelines for an animal test for respiratory sensitisation, however in general respiratory sensitisers are also skin sensitisers.  The lack of any indication of skin sensitisation in the OECD 406 GLP compliant study on CECAJEL 210 (batch No. 9194) (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser.   This data is also considered applicable by read across to the similar chemical 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4.

Justification for classification or non-classification

There is no skin sensitization data for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30 -4, there is however data available for read across from another member of the primary fatty amine ethoxylates family , (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82 -7. These two substances have similar carbon chain distributions and either corrosive or strong irritants to the skin this makes it difficult to perform animal test for skin sensitisation. As this study is available it is not scientifically justified on animal welfare grounds to perform another study on this test substance. 

CECAJEL 210 ((Z)-2,2’-(Octadec-9 -enylimino)bisethanol CAS 13127 -82 -7) was not found to be a skin sensitiser when tested in the OECD 406 study, this indicates that it is unlikely to posses any significant potential for respiratory sensitisation. The physical form of 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30 -4 a waxy solid with a low vapour pressure means inhalation exposure will be minimal. Based on this information it is not classified as a respiratory sensitiser.