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EC number: 411-700-4
CAS number: 140921-24-0
HÄRTER VERSUCHSPRODUKT LS 2959E; HÄRTER VP LS 2959E
Under the conditions investigated the test
substance showed a sensitizing potential to skin.
All animals did not show any symptoms. On day 5 one animal of the group was dead. The following autopsy findings were recorded: coagulated blood in chest and abdomen, liver faded.
After removal of the patches of the second induction (day 9), some animals (animal no. 7, 15, 25, 28, 32) showed wounds in places. On day 10 some animals (animal no. 7, 15, 22, 24, 25, 28, 32, 33, 40) had a crusted skin at the treated areas. These crusts were healed on day 13 (animal no. 22, 24, 28) , on day 14 (animal no. 15) , on day 15 (animal no. 7), on day 16 (animal no. 32, 33, 40), and on day 17 (animal 25).
On day 24 the body weights of the animals of the test substance group and of the first control group were slightly reduced compared to the body weights of the second control group. On day 31 the body weights of the animals of the second control group and of the test item group were reduced and slightly increased, respectively, compared to the body weights recorded on day 24.
The test substance was tested in a Guinea Pig Maximization Test according to EU method B.6 and OECD guideline no. 406. The test substance concentrations selected for the main study were based on the results of preliminary skin irritation tests. In the main study, 20 animals were intradermally induced with a test substance concentration of 5 % in propylene glycol. One week later the test substance in its pure form (100 %) was applied epicutaneously on rabbit’s skin. After 48 hours, the test substance was removed with physiological saline. Ten control animals were similarly treated, but with vehicle only. Three to four weeks after the epicutaneous application all animals were challenged with the test substance in its pure form (100 %). The second challenge was performed with 50 % and 5 % of the test substance. Vehicle was used as control.
After the first challenge 63 % of the treated animals showed signs of skin reactions (redness). The skin of the control animals was unaffected. After the second challenge skin reactions were noted in 63 % and 50 % of the animals treated with 50 % and 5 %, respectively. No skin irritation was observed in control animals.
Body weight was reduced in animals of the treatment group and of control animals after challenge with the test substance compared to control group indicating a slightly systemic effect.
Under the conditions of the experiment, the test substance is considered to have a skin sensitising potential.
Based on the results of the presented study, the test substance was classified for Skin sensitisation in cat. 1B, H317 (may cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP), as amended for the 17th time in Regulation (EU) 2021/849.
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