Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are valid study data available to assess the sensitising potential

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

. No valid information for

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

on respiratory sensitisation is available.

Guideline conform studies:

The dermal sensitizing potential of Octadecanoic acid, 9,10-dihydroxy-, monoammoniumsalt was investigated according to one of the methods recommended in the OECD Guideline No. 406, "Skin Sensitization", 1992 and the EEC Guideline "EEC 92/69 part B6", 1992. The test used was the Buehler Test (Arch. Derm. 91, 171 -177, 1965) (Henkel, BASF PCN, 1997). The experiment was performed on 30 guinea pigs divided into a test group of 20 animals, and a control group of 10 animals. The study included an induction and a challenge phase. The animals in the test group were induced with the test article and the animals in the control group were induced with sterile distilled water. The induction procedure included a closed patch topical application for 6 hours once a week for 3 weeks. The challenge procedure included a closed patch topical treatment of the test article on the flank 4 weeks after the first induction. All animals were challenged for 6 hours. The skin reactions were evaluated 24 and 48 hours after termination of the challenge application. The test article was used undiluted for the inductions and for the challenge. No animal showed reaction not in 24h or 48h reading. In result under the experimental conditions described in this report Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia, caused no evidence of delayed contact hypersensitivity.

Key study assignment:

As there is only one relevant and reliable study available assessing the skin sensitisation of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia and no further results are available, this study is included as key study.

Migrated from Short description of key information:
Skin sensitisation:
Buehler test, guinea-pig, OECD 406, (50%AS): not sensitising, 0/20 positive (Henkel, BASF PCN, 1997)
Respiratory sensitisation:
No data available

Respiratory sensitisation

Endpoint conclusion

Additional information:

Migrated from Short description of key information:
No information available.

Justification for classification or non-classification

Skin sensitisation:

According to GHS and DSD substances shall be classified as skin sensitiser if there are positive results from appropriate animal test. A Buehler test (Henkel, BASF PCN, 1997) shows no positive findings (0/20 tested animals). Hence the substance needs not to be classified according to GHS (Regulation (EU) 1272/2008) as sensitising to skin and also not to be classified according to DPD (67/548/EEC).

Labeling for skin sensitisation:

GHS: no label

DSD: no label

 

Respiratory sensitisation:

No data available.