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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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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