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EC number: 810-394-3 | CAS number: 76326-99-3
Preliminary Irritation Study
Based on the results, the test item concentrations selected for the main study were a 0.5% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure. No signs of irritation were observed to the highest test item concentration epidermally tested. Therefore, the test site of all animals of the main study was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction. A 50% test item concentration was selected for the challenge phase.
FCA = Freunds' Complete Adjuvant
Grading erythema: 0 = No erythema 1 = Slight erythema (barely perceptible) 2 = Well-defined erythema 3 = Moderate erythema
Erythema readings day 3 (intradermal exposure)
1:1 mixture of FCA and water: score 2 (2/5), 3 (3/5)
Vehicle: score 0 (5/5)
1:1 mixture FCA and vehicle: score 2 (3/5), 3 (2/5)
1:1 mixture of FCA and water: score 2 (1/10), 3 (9/10)
0.5% test item : score 1 (9/10), 2 (1/10)
1:1 mixture FCA and 1% test item: score 3 (1/10) other 9 animals showed signs of necrosis at injection site
Erythema, oedema readings day 10 (epidermal exposure)
Vehicle: erythema: score 0 (2/5), 1 (2/5), 2 (1/5), no oedema was observed in any of the animals
50% test item: erythema: score 1 (1/10), 2 (8/10), 3 (1/10), no oedema was observed in any of the animals
The reactions noted in the experimental and control animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.
No skin reactions were evident after the challenge exposure in the experimental and control animals.
Toxicity / Mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Contact hypersensitivity to DMEGA-100 was assessed in the Albino Guinea Pig (Maximisation-Test) according to OECD/EC test guidelines and in compliance with GLP principles. Test item concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with 0.5% DMEGA-100 on day 1 (highest concentration that did not induce local necrosis in the preliminary study) and epidermally exposed to a 50% concentration of DMEGA-100 on day 9. Five control animals were similarly treated, but with vehicle alone (water). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. On day 22, all animals were epidermally challenged with a 50% test item concentration (maximum concentration that could technically be applied) and the vehicle. Adequate negative and positive control groups (alpha-hexylcinnamicaldehyde) were included.
Intradermal injection with DMEGA-100 resulted in slight erythema on day 3 and epidermal exposure resulted in well-defined erythema. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that DMEGA-100 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 50% test item concentration in the challenge phase. This result indicates a sensitization rate of 0%. The reliability check with Alpha-hexylcinnamicaldehyde indicates that the GMPT is an adequate test system for the evaluation of the sensitizing potential of a test item.
Based on these results DMEGA-100 does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and EC criteria for classification and labelling requirements for dangerous items and preparations (Council Directive 67/548/EEC) (including all amendments).
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