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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.
All available skin sensitisation studies showed that Fatty Acid Glycerides are not skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information are included as attachment to the same record, see links in 'Cross-reference' table

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
[Describe why the read-across can be performed (e.g. common functional group(s), common precursor(s)/breakdown product(s) or common mechanism(s) of action]
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study was conducted before the REACH Regulation came into force.
Key result
Reading:
other: Summary
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no abnormalities
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
All available skin sensitisation studies showed that Fatty Acid Glycerides are not skin sensitising.
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 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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study 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.