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EC number: 285-547-5
CAS number: 85116-93-4
There were no skin sensitisation
studies conducted for the Fatty Acid Polyol with the CAS No. 85116-93-4
(Fatty acids, C16-18, esters with pentaerythritol). Data from studies of
structural analogues, conducted according to OECD Guideline 406 (Buehler
Test) and OECD Guideline 429 (Local Lymph Node Assay), were used for
The skin sensitization potential of the
Fatty Acid Polyol with CAS No. 68424-31-7 (Fatty acids, C5-10, esters
with pentaerythritol) was evaluated in guinea pigs with a Buehler test
for skin sensitisation (RA-S, CAS 68424-31-7, Lees, 1991, Croda, Skin
sens., RL2). 20 male albino guinea pigs were treated with the test
substance and compared with 10 control animals. Three epidermal
inductions were performed with 100 % test substance in weekly intervals
for 6 hours under occlusive conditions. 14 days after the last induction
treatment, all animals were challenged for 6 hours epicutaneously with
100% (left shorn flank) and 30% (right shorn flank) test substance
(diluted in corn oil) under occlusive conditions. Animals were evaluated
for skin reactions 24 and 48 h after challenge. No signs for irritation
or sensitisation were observed during induction and challenge of the
Furthermore, a Local Lymph Node Assay
was conducted with the same substance (CAS No. 68424-31-7, Fatty acids,
C5-10, esters with pentaerythritol). The test substance was applied in
concentrations of 3%, 10% and 30% on three consecutive days to the
dorsum of both ears of 4 female CBA/Ca mice each. Five days later the
animals received approx. 20 µCi of 3H-methly thymidine and were
sacrificed 5 h later for measurement of radioactivity. No significant
increase in isotope incorporation was detected after repeated
application. The stimulation index, calculated by comparison of the Cpm
of the control and the treated animals, was 0.45 for the 3% application,
2.05 for 10% and 1.21 for the 30% application (RA-S, CAS 68424-31-7,
Key, Robinson, 1991, Croda, Skin sens., RL2).
The available data from structural analogue substances does not indicate
a potential for skin sensitisation.
According to the DSD and CLP criteria for classification and labelling
of dangerous substances CAS No. 85116-93-4 (Fatty acids, C16-18, esters
with pentaerythritol) is not classified as sensitising to the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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