Glycerides, C12-18 mono-, di- and tri-

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.

 

Overview of Skin Sensitisation

CAS	Skin Sensitisation
555-43-1	Experimental result: not sensitising
736150-63-3	Experimental result: not sensitising

 

Skin sensitisation

CAS No. 555-43-1

Glycerol tristearate was investigated in male and female guinea pigs in a GLP-conform Buehler test according to OECD 406 (Krueger, 1998). In a preliminary skin irritation test with 3 female animals, test substance formulations of 10, 20, 30 and 50% in petrolatum were topically applied to the flank under occlusive conditions for 6 h in order to establish a non-irritant concentration for induction. The concentration for challenge exposure was determined in a further 4-week test on 3 animals using the same concentrations. The maximum non-irritant concentration of 50% was used for topical application in the induction and challenge phase of the main assay. In the induction phase, the test substance at concentrations of 50% in petrolatum was applied to the clipped skin of the left flank of 20 animals using an occlusive dressing. During induction, three consecutive topical applications for a period of 6 h each were performed at intervals of 7 days. A control group of 10 animals was treated with the vehicle. For challenge exposure on Day 28, the test substance at 50% concentration in petrolatum and the vehicle only was applied for 6 h to the clipped skin of the posterior and anterior right flank of all animals, respectively. Skin reactions were evaluated 24 and 48 after application. None of the treated animals of the test and control group showed symptoms of dermal irritation after challenge treatment. No test substance-related systemic effects and no effects on body weights were observed in the test or control animals. The positive control substance α-hexyl cinnamic aldehyde showed the expected results thereby confirming the reliability of the study. Based on these results and the experimental conditions chosen, the test substance had no skin sensitising effect in guinea pigs.

A human patch test was performed in 9 volunteers with a known contact allergy to olive oil to assess the skin sensitisation Glycerol tristearate (Malmkvist Padoan et al., 1990). The test substance at 30% concentration was applied to a patch and occlusively placed on the skin for a period of 48 h. After exposure, the test substance was removed and skin reactions were assessed 72 h post-application according to ICDRG recommendations (Fregert and Bandmann, 1975). In 9 of 13 volunteers the test substance did not induce any skin reactions. Based on the results of this patch test, the test substance at 30% concentration did not induce skin sensitisation in humans.

CAS No. 736150-63-3

The skin sensitising potential of Glycerides, castor-oil.mono, hydrogenated, acetates was investigated in a Local Lymph Node Assay (LLNA) in mice performed according to OECD guideline 429 and in compliance with GLP (Meurer, 2007). In this study, 5 female CBA7CaOlaHsd mice per test group were treated with test substance at 10, 20 and 50% (w/v) in dimethyl sulfoxide or vehicle alone, respectively. The test substance formulations or the vehicle were applied topically to the dorsal surface of each ear lobe (25 µL/ear) for three consecutive days. Different batches (A-D) were used for treatment with the test substance at the respective concentrations. Five days after the first topical application, animals were sacrificed and the cell proliferation of pooled lymph nodes from individual animals was measured by incorporation of ³H-methyl thymidine and expressed as the amount of radioactive disintegration per minute (DPM). For batch A, the mean DPM/lymph node for each test group was 1528.3, 2088.3 and 3468.7 at concentrations of 10, 20 and 50% of the test substance, respectively. At 50% concentration of Batch A, a statistically significant difference (p ≤ 0.05) in DPM per lymph node was observed compared to control (DPM/node = 2027.9). Based on these results, stimulation indices of 0.75, 1.03 and 1.71 were calculated for the treatment concentrations of 10, 20 and 50%, respectively. The animals treated with the mid and the highest concentration (25% and 50%) of Batch A showed reddening of the ear skin from the second day of treatment. In summary, stimulation indices at of maximal 0.97 in the 10% groups, 1.53 in the 25% groups and 1.86 in the 50% groups were observed after treatment with the batches A-D of the test substance. Based on this data, no EC3 values of the test groups could be calculated, since none of the tested concentrations induced a stimulation index greater than 3. The positive control substance (25% hexyl cinnamic aldehyde in acetone:olive oil (4+1)) induced positive reactions in 2/5 animals (40%) and thus confirmed the sensitivity and reliability of the experimental technique. Under the above mentioned conditions, the test substance was not found to be a sensitiser in the LLNA.

Overall conclusion for skin sensitisation

No skin sensitising potential was observed in the available study.

Based on the available data and following the analogue approach, Glycerides, C12-18 mono-, di- and tri- is considered to be not skin sensitising.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the analogue approach, the available data on skin sensitisation do not meet the classification

criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive

but not sufficient for classification.

So Glycerides, C12-18 mono-, di- and tri- has non-classification for skin sensitisation.