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EC number: 236-770-1 | CAS number: 13477-62-8
Skin irritation (similar to OECD TG 404): irritating (BASF 1983; 83/186) Eye irritation (OECD TG 405): not irritating (BASF 1983; 83/186)
In the chosen key primary dermal irritation study similar to OECD TG 404, Vienna white rabbits (3 females) were dermally exposed (occlusive) to unchanged tetrahydro-2-isobutyl-4-methyl-2H-pyran for 4 hours (BASF 1983; 83/186). Mean scores (24 -72 hours) for each animal were 2.0, 2.0 and 1.7 for erythema and edema, respectively. Erythema were not reversible in all animals within 8 days after removal of the patch, i.e. end of the observation period.
In a supportive study with comparable testing protocol, 50%, 25% and 10% tetrahydro-2-isobutyl-4-methyl-2H-pyran in vaseline was dermally applied to Vienna white rabbits (2 males, 1 female) under occlusion for 4 hours (BASF 1984; 83/186). Very slight to clearly remarkable skin irritation (fully reversible within 8 days) has been observed after application of the test substance at 50% in vaseline. Very slight skin irritation (fully reversible within 48 hours) has been observed after application of the test substance at 25% in vaseline. Application of 10% test substance in vaseline showed no skin irritation.
In a supportive study according to OECD TG 404 and GLP, young adult white rabbits (3 males) were dermally exposed (semiocclusive) to unchanged structural analogue rose oxide for 4 hours (BASF 2007; BASF18H0624/072134). Rose oxide shares a high structural similarity but varies in the presence of a double bond as putative reactive structural feature. Mean scores (24 -72 hours) for each animal were 3.0, 3.0 and 3.3 for erythema respectively. Mean scores (24 -72 hours) for edema were 1.0 for each animal. Erythema were not reversible in all animals within 14 days after removal of the patch.
Overall, mean scores for erythema/edema observed were equal to 2 but not above 2.3 in the key study in 2/3 animals. The full reversibility for skin findings has not been demonstrated. Furthermore, the findings with the structurally similar rose oxide do not exclude a persistence of effects for a longer duration than examined in the key study. Therefore, tetrahydro-2-isobutyl-4-methyl-2H-pyran is considered to be irritating to skin.
In the chosen key tetrahydro-2-isobutyl-4-methyl-2H-pyran has been tested in 3 Vienna white rabbits according to OECD TG 405 (BASF 1983; 83/186). Unchanged tetrahydro-2-isobutyl-4-methyl-2H-pyran was instilled into the right eye of each rabbit (0.1 mL). No effects in terms of corneal opacity and iritis have been observed. Chemosis with a score of 1 for each animal was observed at the 1 hour reading only. Mean scores of 1 for conjunctival redness (24, 48 and 72 hour observation time point) was observed for each animal but was fully reversible within 8 days. Overall, tetrahydro-2-isobutyl-4-methyl-2H-pyran showed little eye irritation potential under the chosen testing conditions.
The present data fulfill the criteria laid down in regulation (EU) 1272/2008, and a classification "irritating to skin" (R38) and "skin irritant" (category 2) is warranted.
The present data on eye irritation do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.
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