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EC number: 907-672-2 | CAS number: -
Animal and human data are available to evaluate skin irritation. DBPP is considered not irritant for the skin.Two K4-ranked in vivo studies are available for eye irritation. A weight-of-evidence approach was applied. DBPP is considered to be not an eye irritant.
After 2 hours one animal showed barely perceptible erythema. The other 2 animals received a score of zero. Overnight the trace of erythema on the affected animal disappeared.
The compound was found to be practically non-irritating when applied to intact rabbit skin.
Animal data from two study reports were available. However, both were assigned a Klimisch score of 4. In the oldest study (Younger, 1956), DBPP was found to be practically non-irritating when applied to the intact skin of rabbits. In the other study (Branch, 1979), Acryloid HF-422, a formulation of 70.8% DBPP and 29.2% n-butylmethacrylate polymer, was applied on the skin of New Zealand rabbits. And also this formulation was not a skin irritant.
Apart from the animal data there is a repeated insult patch test with human volunteers available.
In the repeated insult patch test with DBPP (Shelanski, 1974), the test material was applied on the human skin of 50 human volunteers. After an exposure period of 24 h the patch was removed and the skin sites were examined. Gross changes, if present, were graded on a scale of 1 to 4. Absence of any visible changes were assigned a 0 value.
After the first exposure, no visible skin changes signifying reaction to injury were recorded.
There are two in vivo eye irritation studies available (Younger, 1956; Branch, 1979). Since both were ranked with a K4 Klimisch score, a weight of evidence approach was applied.
In the oldest study (Younger, 1956), 0.1 mL of undiluted sample was placed in the conjunctival sac of the right eye of each of three albino rabbits and the resulting irritation was scored according to the method of Draize et al. (1944). Eye irritation in rabbits consisted of slight redness of the conjuctivae with some discharge and a trace of swelling for an average score after one hour of 5.3 out of a possible 110. After 48 h two of the animals were free of inflammation and after 72 h all three animals were scored 0. The author of the study report concluded that DBPP is a rather mild ocular irritant.
In the other study (Branch, 1979), 0.1 mL of Acryloid HF-422 was applied to the eyes of six New Zealand rabbits. The test substance Acryloid HF-422 is a formulation of 70.8% DBPP and 29.2% n-butylmethacrylate polymer. The average score was respectively 3.5, 2.3 and 2.0 out of a maximum score of 110 after 24, 48 and 72h.
Information from the animal studies indicated that the substance is not a skin irritant. Additionally, DBPP did not score positive after a 24h exposure period on the human skin of 50 volunteers. Based on this information, DBPP is not classified as a skin irritant according to the CLP Regulation.
In both evaluated study reports, in less than 2 of 3 tested animals, a positive response of corneal opacity ≥1 and/or iritis ≥ 1 and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, was calculated as the mean scores following grading at 24, 48 and 72 hours. Based on these results and the criteria described in the CLP Regulation, DBPP is not classified as an eye irritant.
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