Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, dioleates

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Cross-reading betweenfrom Oleyl-diamine dioleate to Tallow-diamine dioleateis acceptable on the basis ofidentical chemicalstructures. The only differences between the two substances are related to the alkyl-chains linked to the diamine.Contrary to oleyl do tallow-alkyl chains also contain some C16-chains next to the C18-alkyl chains.The toxicological relevance of this difference is expected to be negligible. The higher level of unsaturation in oleyl-alkyl chainscompared to tallow-alkyl chainscan be considered a worst case representationwith respect to possible sensitising properties whencompared to tallow. Due to this very great similarity between these two substances, results obtained from Oleyl-diamine dioleatearefully applicable for the evaluation of Tallow-diamine dioleate as well.

 

Oley-diamine dioleate was tested for skin sensitization potential in guinea pigs according to OECD 406 guidelines on the maximization method of Magnusson and Kligman, and in compliance to GLP.

Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treatment group of ten males and ten females. An additional control group of five males and five females was also used for a second challenge application. Applied dose levels were based on the results of a preliminary study.

Induction scheme consisted of intradermal injections of a concentration of 0.1% in corn oil, and 7 days later a topical application of the test item at the concentration of 25% (w/w) in acetone for 48 hours under occlusion. The induction exposures resulted to appropriate levels of irritation.

Three weeks after the start of the induction all animals were challenged by a cutaneous application of the test item at the concentration of 10% (w/w) in acetone for 24 hours under occlusion. As equivocal cutaneous reactions were noted after the first challenge, a second challenge application was performed on day 40 with the original control and treated groups and with a new control group of ten animals.

No systemic clinical signs and no deaths related to treatment were noted during the study. Due to too severe local reactions following intradermal injections, two animals were sacrificed for ethical reasons.

At first challenge, 5 (50%) control animals reacted positive, and in the treated group 11 of the 18 (61%) animals (7 after 24 hrs and 10 after 48 hours).

The second challenge with 5% resulted to 3/10 positive reactions in the first control group and none in the second control group. In the group of treated animals, a discrete or moderate erythema was observed in 2/18 animals at the 24-hour reading. A discrete erythema, together with dryness of the skin in one animal, persisted at the 48-hour reading in these two animals. No reactions were observed in any of the control and treated animals following 1% application.

Migrated from Short description of key information:
Oley-diamine dioleate was shown not to be sensitizing in a recent Guinea pig study following the Magnusson and Kligman Maximisation Method.

Justification for selection of skin sensitisation endpoint:
Only one study available, based on cross-reading from substance with same structure.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There is no information on respiratory sensitisation. However, no concerns are expected.

As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non respiratory sensitisation of the substance.

Additionally, the likelihood for exposure via inhalation and thus becoming sensitised to Tallow-diamine dioleate is very low as result to the exposure via inhalation route. Tallow-diamine dioleate is a solid at 20°C with a melting point of 38 °C. It has avapour pressure less than 0.0015 Pa at 20°C (value is an overestimation as it is based on read-across from C12-14-diaminerather than a dioleic acid salt of an alkyl diamine as Tallow-diamine dioleate salt)and the indicated use pattern also does not give rise to a high concern for specific exposures via inhalation.

Migrated from Short description of key information:
As suggested in REACH guidance R7a. (R.7.3.5 Information and its sources on respiratory sensitisation), the negative results on skin sensitisation from an adequately performed appropriate test can also be regarded as lacking the potential to cause allergic sensitisation of the respiratory tract.

Justification for classification or non-classification

Oleyl-diamine dioleate has shown to be non-sensitising in a adequately performed Guinea pig study following the Magnusson and Kligman Maximisation Method. This is directly valid for Tallow-diamine dioleate on the basis of the same chemical structure. Consequently, the substance does not need to be classified for sensitisation.

These negative results for skin sensitisation can also be regarded as indicating the lack of the potential to cause allergic sensitisation of the respiratory tract.