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EC number: 236-244-1 | CAS number: 13254-34-7
in vitro Skin irritation data do not need to be conducted as adequate in vivo skin irritation data exist to classify DIMETOL.
Two in vivo rabbit skin irritation studies are available to consider in a weight of the evidence apporach. Both pre-date GLP guidelines. The first study is an acute dermal toxicity study performed in 10 rabbits with a dose of 5 g/kg. Observations included moderate edema and moderate erythema in a majority of the animals. The second study used 6 rabbits to determine the primary irritant properties of DIMETOL applied neat. The primary irritation index was 5.13.
Both studies indicate DIMETOL can be irritating to the skin.
in vitro Eye irritation data do not need to be conducted as adequate in vivo eye irritation data exist to classify DIMETOL.
Two in vivo rabbit eye irritation studies are available to consider in a weight of the evidence approach. Both pre-date GLP guidelines. The first study instillation of 0.1 mL of 5% test material into the right eye of each of three rabbits, in the manner described, produced a moderate conjunctival irritation. On the seventh day of observation these eyes were normal. In the second study neat material instilled into the rabbits' eyes produced a primary irritation index: 536 / 18 = 29.8. The pathological findings on the eye and the irritations on the mucous membrane were not reversible within 8 days. Based on the findings the substance must be considered to be moderately irritant.
Taken together, these studies justify classification of DIMETOL as a serious eye irritant under GHS and as an eye irritant DSD schemes.
Ten rabbits were dosed with 5 g/kg, irritant effects were observed. Slight redness in 2, moderate redness in 8, slight edema in 1, and moderate edema in 9 of the animals were observed.
Based on a weight of the evidence approach DIMETOL is classified as irritating to the skin.
Based on a weight of the evidence approach DIMETOL is classified as a serious eye irritant for GHS and as an eye irritant for DSD.
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