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:

Glyceride, C16-18- und C18-Hydroxymono- und Di- (CAS No. 91845-19-1) was tested for its skin sensitisation potential according to 79(831/EWG, Annex V, Part B), (Kästner, 1985). 20 Pirbright white guinea pigs were tested in a Guinea pig maximization test and compared with 20 negative control animals. Induction exposure was performed with the test substance at a concentration of 50 % in paraffin oil (1%) for intradermal application and in vaseline (50%) for epicutaneous application. Challenge treatment was performed by dermal application of the test substance at 25 % in vaseline. 24 and 48 hours after challenge exposure all skin examination scores were zero.

 

2,3-dihydroxypropyl laurate (CAS No. 142-18-7) was tested for its skin sensitisation potential in a Buehler test performed similar to OECD Guideline 406 (Sterner 1977). 10 Pirbright guinea pigs were tested and compared with 5 negative control animals. Three epicutaneous induction exposures were performed with the test substance at a concentration of 25 % in water. Epicutaneous challenge treatment was performed with the test substance at 25 % in water. 24 and 48 hours after challenge exposure all skin examination scores were zero.

 

Glycerol tristearate (CAS No. 555 -43 -1) was tested for its skin sensitisation potential according to OECD Guideline 406 (Krueger, 1998). The sensitivity of the guinea pig strain was confirmed by a Buehler test performed with alpha-hexylcinnamaldehyde. Twenty Dunkin-Hartley guinea pigs were tested in a Buehler test and compared with ten negative control animals. Three epicutaneous induction exposures were performed with the test substance at a concentration of 50 % in vaseline. Epicutaneous challenge treatment was performed with the test substance at 50 % in vaseline. 24 and 48 hours after challenge exposure all skin examination scores were zero.

 

Propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) was tested for its skin sensitisation potential according to OECD Guideline 406 (Mürmann, 1993). Twenty Dunkin-Hartley guinea pigs were tested in a Buehler test and compared with ten negative control animals. Three epicutaneous induction exposures were performed with the unchanged test substance at a concentration of 100 %. Epicutaneous challenge treatment was performed with the test substance at 100 %. 24 and 48 hours after challenge exposure all skin examination scores were zero. .

 

Triglycerides, mixed decanoyl and octanoyl (CAS No. 73398-61-5) was tested for its skin sensitisation potential in a human Repeated Insult Patch Test (Eisenberg, 1996). 54 volunteers were induced epicutaneously (interscapular back skin) with 0.2 mL of the unchanged test substance for a exposure duration of 24 hours under semi-occlusive conditions. Inductions were performed three times a week for a total of ten applications. The challenge application was performed two weeks after the last induction on the volar forearm. 24 and 48 hours after challenge application the volar forearm was observed for skin irritation. None of the 54 tested volunteers showed any skin reactions, indicating that the test material has no skin sensitising potential in human skin.

 

Triglycerides, mixed decanoyl and octanoyl (CAS No. 73398-61-5) was tested for its skin sensitisation potential using a Buehler test method (Consultox, 1972). Six guinea pigs were tested in a Buehler test and compared with negative control animals. Ten epicutaneous induction exposures were performed with the test substance at a concentration of 4 % in ethanol. Epicutaneous challenge treatment was performed with the test substance at 4 % in ethanol. No range finding tests were reported. No skin reactions were observed in any of the six tested animals.

 


Migrated from Short description of key information:
Studies on skin sensitisation of were available for the following Fatty Acid Glycerides category members (CAS No.):
91845-19-1, 620-67-7, 142-18-7, 555-43-1, 73398-61-5 (animal and human skin sensitisation test).
All available skin sensitisation studies showed that Fatty Acid Glycerides are not skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No studies available.

Justification for classification or non-classification

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for sensitisation, no classification is required.