Registration Dossier

Administrative data

Description of key information

Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates is not considered to be sensitizing to the skin.

Key value for chemical safety assessment

Skin sensitisation

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

No information on skin sensitisation of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates was identified. However, two studies from structural analogues are available.

In a Guinea Pig Maximisation Test according to OECD TG 406 under GLP conditions, the skin sensitizing potential of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts (CAS 91744 -39 -7) was assessed, using 10 test and 5 control animals (Goldschmidt AG, 1996). Based on a range finding tests, the animals were exposed (epicutaneous, occlusive) to 50% of the test substance prepared in vaseline after a series of intradermal injections (5% test substance). The animals were subjected two weeks later to a challenge exposure with the test substance and the control substance for the control group. Responses to the challenge procedure were evaluated 24 and 48 h after the end of the exposure period. No allergic skin reactions occurred in test animals 24 and 48 h after the end of the challenge procedure. The sensitisation rate was 0 %. No findings were observed in control animals. Based on these results, it was concluded that the test substance does not have a sensitising effect on the skin of the guinea pig in the Buehler test under the test conditions chosen.

The sensitizing potential of the test substance (CAS 91744-23-9) was investigated in a study according to OECD Guideline No. 406 "Skin Sensitization (maximization test)”. The following animal numbers were used in the study: 20 (main experiment), 3 (pilot study), 3 (determination of challenge concentration), control animals: 10. The substance concentrations for induction and challenge were 2, 25, 50, and 100 % in corn oil MEH 56. 2 -Mercaptobenzothiazole served as positive control. Experimental animals were epidermally exposed to undiluted test substance on days 0, 7, and 14 (occlusive dermal applications for 6 hours, scoring at 30 hours after start of application). Control animals were exposed to vehicle only. On day 28 animals were challenged with undiluted test substance (occlusive dermal application for 6 hours). Evaluations were made after 24 and 48 h.

Under the conditions of the test no sensitizing effects of the test substance could be observed. In addition, no clinical effects were observed. Body weight increase of the test animals was comparable to the control. Based on these results, it was concluded that the test substance does not have a sensitising effect on the skin of the guinea pig in the Guinea Pig Maximisation Test under the test conditions chosen.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No information on respiratory sensitisation of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates was identified.

Justification for classification or non-classification

Based on the available information, classification for skin sensitisation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.