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 a skin sensitisation study for a similar primary fatty amine ethoxylate, based on a different fatty acid. This related substance (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, is based on a fatty acid which is predominatly (>80%) C18 and C18 unsaturated. 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 is based on the same amine but consists of a range of fatty acid chain lengths C12, C14, C16 and C18, there is typically >50% C12 but also >10% of the other carbon chain lengths. Chemicals that induce skin sensitisation have to firstly react with proteins in the skin to from a hapten and which can then be detected as foreign by the immune system. It has been postulated that some fatty acids may have skin sensitising potential related to their degree of unsaturation leading to increased reactivity. If unsaturation does provide potential for skin sensitisation the (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, would be expected to have more potential then the 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2. Therefore read across to this substance is considered to be very unlikely to underestimate any skin sensitisation potential of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol. Any potential reactivity involving the amine part of the molecule either directly or following metabolism in the skin would be expected to be very similar for both substances. Based on this, in the absence of any specific data on 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 and the difficulty in providing this data due to animal welfare considerations in testing a corrosive substance, read across has been used to the data available for(Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7.

 

The potential of the test item (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.

On day 8, the animals of the treated group received a topical application of 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 (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, does not induce delayed contact hypersensitivity in guinea pigs.

Migrated from Short description of key information:

There are no studies on skin sensitisation in animals available for 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2.  The skin irritation study in rabbits showed the test substance to be corrosive, which makes it very difficult to perform animal studies for skin sensitisation due to animal welfare considerations.  

There is data on a similar substnace (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7. The potential of the test item (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.  (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, did not induce delayed contact hypersensitivity in guinea pigs.

Respiratory sensitisation

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

Read across to (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7 is considered to be very unlikely to underestimate any skin sensitisation potential of 2, 2’-(C12-18 evennumbered alkyl imino) diethanol. Any potential reactivity involving the amine part of the molecule either directly or following metabolism in the skin would be expected to be very similar for both substances. Based on this, in the absence of any specific data on 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 and the difficulty in providing this data due to animal welfare considerations in testing a corrosive substance, read across has been used to the data available for(Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7.

 

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 (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser. This also indicates that 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 is also unlikely to be a respiratory sensitiser.

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 (Z)-2,2’-(Octadec-9-enylimino)bisethanol CAS 13127-82-7, indicates that it is unlikely to be a respiratory sensitiser. Based on this it is not expected that 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2 would cause respiratory sensitisation.

Justification for classification or non-classification

((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 sensitisationThe physical form of this substance a liquid with a low vapour pressure means inhalation exposure will be minimal. Based on this information it is not classified as a respiratory sensitiser