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EC number: 701-259-9 | CAS number: -
A number of studies are available for read-across substances.
Ethylhexyl palmitate was identified as a non-sensitiser.
The salient differences of this QSTR model for skin sensitization based on the GPMT assay compared with prior publications include: (1) a considerably larger training set, and thus broader application domain encompassing wider chemical diversity.
(2) that the model resolves the strength of sensitization into weak/moderate and strong categories
(3) that the use of OPS ensures that only query compounds that fit within the model's domain will be assessed, thus avoiding the production and distribution of invalid results--this capability does not, and cannot, exist in expert systems such as DEREK.
The limitations of this QSTR model are basically:
(I) that the GPMT, due to its very nature, tends to overpredict sensitization compared with assays in humans,
(2) that the training set, extensive though it may be, does not encompass as many compounds and as much chemical diversity as one might wish --the release of proprietary data by manufacturers would greatly remediate this problem; and
(3) no account has been taken of previously identified modes of a c t i o n - - b e t t e r models would probably result if submodels were limited to compounds with a single mode of action
Despite these relative pros and cons, the QSAR model did predict the nonsensitising nature of Ethylhexyl palmitate, as indicated in prior literature.
No further information on results
Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy materials. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.
It was concluded that the test material was not sensitising. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.
In this human repeat insult patch test, ethyl hexylpalmitate was applied to 25 healthy adult volunteers on five occasions during induction and then 10 days later a topical challenge dose was applied. No signs of sensitisation or irritation were observed.
A maximization test was carried out on 25 volunteers. The material (RIFM no. 77-478) was tested at a concentration of 4% in petrolatum and produced no sensitization reactions. A human patch test in 25 volunteers resulted in no indications of sensitisation when challenged with 4% ethylhexyl palmitate.
Several investigations included analogous materials or other UVCBs in an assessment of sensitising potential. Ethyl hexyl palmitate was investigated by Kligman, in a human repeat insult patch test, no signs of sensitisation or irritation were observed. Weil investigated the sensitising potential of ESBO in an open epicutaneous assay - no signs of sensitisation were evident. Ethyl hexyl palmitate was investigated as part of a review of fragrance additives. A 4% solution applied at challenge in ahuman repeat insult patch test resulted in no evidence ofsensitisation. As part of QSAR modeling validation, ethylhexyl palmitate was also identified as non-sensitising.
Sensitisation studies performed with read-across substances show that fatty acids C12 -20 and C12 -20 unsaturated, 2 -ethylhexyl esters do not require classification as potential skin sensitisers under the CLP Regulation.
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