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EC number: 692-614-6
CAS number: 5660-53-7
Clinical signs and mortality:
No systemic toxicity was observed during the period of test among the
control animals. On Day 11, one female from the treated group was found
dead; this mortality represents less than 10% of total animals and was
considered without impact on the study outcome. All surviving animals
had normal body weight gain during the experimental period.
Neither erythema nor edema was observed in the left flank during the
period of the test.
sensitizing study was performed with
2-isobutyl-2-methyl-1,3-dioxolane-4-methanol in Dunkin-Hartley guinea
pigs according to the Buehler test method (OECD 406 Guideline) and in
compliance with the GLP.
preliminary test was carried out initially with one male and one female.
Test substance (0.5 mL) was applied dermally undiluted (100%). Since no
irritation was observed in both animals, the concentration of 100% was
applied in the main test.
In the main
test, thirty adults and healthy guinea pigs were divided in 2 groups:
treatment group with 10 animals/sex and control group with 5
animals/sex. In the period of induction, three applications were carried
out on the left flank of each animal using an occlusive patch fully
loaded with 0.5 mL of the test substance undiluted (treatment group) or
0.5 mL of deionized water
(control group), held in contact for 6 hours on days 0, 7 and 15. On day
11, one female from the treated group was found dead; this mortality
represents less than 10% of total animals and was considered without
impact on the study outcome. At day 27, challenge exposure was started:
an occlusive patch fully loaded with 0.5 mL of the test substance
undiluted was applied to the right untreated flank of both treated and
control animals. The patches were held in contact for 6 hours.
Approximately 24 and 48 hours after removing the patches, skin reactions
(development of edema and erythema) were evaluated. Neither erythema nor
edema was observed in any animals. No clinical signs of toxicity and no
effect on body weight gain were observed during the experimental period.
conclusion, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol does not
require classification as a skin sensitizer according to the Regulation
(EC) 1272/2008 (CLP) and GHS UN criteria.
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