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EC number: 235-834-6 | CAS number: 13001-38-2
Skin effects after intradermal induction performed on test day 1
The expected and common findings were observed in the control and test group after the different applications using FCA intradermally. These findings consisted of erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation.
Skin effects after epidermal induction performed on test day 8
Control group: discrete/patchy erythema was observed at the 24- and 48-hour reading in four out of 5 animals after treatment with PEG 300 only.
Test group: discrete/patchy erythema was observed in all animals at the 24- and 48-hour reading after treatment with the test item at 40 % in PEG 300. Although the test item at 40 % stained the skin yellow, it was still possible to determine whether erythema was present or not. The reactions observed in both groups occurred following pretreatment with 10 % SLS in paraffinum perliquidum.
Skin effects after challenge - performed on test day 22
Control group: no skin reactions were observed in the animals when treated with either PEG 300 only or when treated with the test item at 40 % in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
Test group: no skin reactions were observed in the 9 surviving animals when treated with either PEG 300 only or when treated with the test item at 40 % in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
Viability / mortality / macroscopic findings: one animal of the test group was found dead on test day 18 (i.e., 6 days after the 48-hour reading of the epidermal induction phase). At necropsy, congestion in the lungs was noted. The cause of death could not be established.
Clinical signs, systemic: no signs of systemic toxicity were observed in the animals.
Body weights: body weight of the animals was within the range commonly recorded for animals of this strain and age.
A maximisation test was performed in 15 (10 test and 5 control) male albino guinea pigs to assess the skin sensitising potential, in accordance with OECD guideline 406 and EU method B.6. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 10 % dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.
The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the test item at 40 % in PEG 300 one week after the intradermal induction and following pretreatment of the test areas with 10 % Sodium- Lauryl-Sulfate (SLS) approximately 23 hours prior to application of the test item.
Animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion following pretreatment with 10 % SLS.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 40 % in PEG 300 and PEG 300 alone under occlusive dressing for 24 hours.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Skin reactions after the challenge procedure
% of positive
(in 5 animals)
(in 9 animals)*
* One animal was found dead on test day 18. At necropsy, congestion in the lungs was noted. The cause of death could not be established.
No signs of toxicity were evident in the guinea pigs of the control or test group. None of the 9 surviving test animals showed skin reactions after the challenge treatment at 40 % (w/w) in PEG 300. No skin effect was observed in the control group. The substance was considered as not skin sensitising.
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