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EC number: 274-581-6 | CAS number: 70356-09-1
The in vivo skin irritation study with the rabbit revealed no to moderate formation of erythema and no to very slight edema formation, with all effects being fully reversible. In the two in vivo eye irritation studies with the rabbit very slight conjunctivae redness was observed, the effect was fully reversible. BMBDM therefore is not to be considered as skin irritant or eye irritant.
Table 2: Primary irritation index after 4h exposure of 10% BMDBM in ethanol/2-phenylethanol (50/50) to intact and abraded skin:
Table 3: Primary irritation index after 4h exposure of the vehicle (ethanol/2-phenylethanol (50/50)) to intact and abraded skin:
After occlusive application of 0.5mL of the test item (10% BMDBM solved in ethanol/2-phenylethanol (50/50)) for 4 hours to intact or abraded rabbit skin, no to moderate formation of erythema and no to very slight edema formation was noted. The mean scores (erythema/edema) were 0.83/0.17 on intact skin and 1.33/1.00 on abraded skin 24h after application. Testing the solvent caused no to very slight erythema and edema resulting in scores (erythema/edema) of 0.50/0.00 on intact skin and 1.17/1.00 on abraded skin 24h after application. It can therefore be concluded that the skin irritations are mainly due to the vehicle used and that BMDBM bears very slight irritating potential.
As the erythema/edema score is <2.3 in all animals no classification as skin irritant according to OECD GHS is needed
The determination of eye irritating effects of butyl methoxydibenzoylmethane (BMDBM) was performed in a study similar to OECD Guideline 405 on three rabbits: BMDBM as 5%, 10%, and 20% solution in diethylphtalate was placed in the conjunctival sac of one rabbit eye and the effects are recorded after 1h, 24h, 48h, 72h, 7 days and 14 days. Observations comprised opacity of the cornea, iris reaction, conjunctival redness and swelling (chemosis).
The instillation of a solution of BMDBM caused concentration-dependent weak conjunctival irritation of the rabbit eye which was fully reversible within up to 3 days. The mean irritation scores for the 20% solution (3 animals, 24 - 72h after administration) were 0 (Cornea opacity), 0 (Iris), 0.67 (Conjunctivae redness), 0 (Chemosis).
Therefore, BMDBM can be considered as non-irritant to the eye and no classification according to EU CLP is needed.
In the study by Kleczak (1982), skin irritation was tested by occlusive application of a 10% BMDBM solution for 4h on intact or abraded rabbit skin. The results revealed no to moderate formation of erythema and no to very slight formation of edema. Testing the solvent caused no to very slight erythema and edema formation.
Therefore, the authors concluded that the irritating potential can mainly be attributed to the solvent used and that BMDBM is at best slightly irritating to skin.
In two studies by Kleczak (1988 and 1978), eye irritation was tested in the rabbit eye. Both test items, which were a sunscreen cream containing 3% BMDBM and different BMDBM solutions (5-20% BMDBM), caused only very slight conjunctival redness (grade 1 of 4) which was fully reversible within 2-3 days. Therefore, BMDBM can be considered as not irritating to the eyes.
No classification-relevant skin irritating and eye irritating effects were observed in the respective in vivo studies, thus no classification applicable.
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