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EC number: 232-556-7 | CAS number: 9000-72-0 Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Styrax, Styracaceae).
Skin sensitisation (OECD TG 429): Sensitising (calculated EC3 of 4.8%)
Calculation of the EC3 Value by Means of Extrapolation:
EC3 = Estimated concentration for a S.I. of 3.
a,b,c,d = Co-ordinates of the two pairs of data lying immediately above the S.I. value of 3 on the LLNA dose response plot. The point with the higher S.I. is denoted as (a, b). The point with the lower S.I. is denoted as (c, d).
In the study the test item Benzoin Laos Orpur 50%/DPG dissolved in dimethylformamide was assessed for its possible skin sensitising potential in accordance with OECD TG 429. For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50% (w/w). The highest concentration tested was the highest concentration that was technically feasible and which did not cause systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On days 2-6, the animals treated with a test item concentration of 50 % showed an erythema of the ear skin (days 2, 3, 4, 6: Score 1; day 5: Score 2). No statistically significant increases in ear thickness or ear weights were observed. Under the conditions of the test the substance was considered sensitising and resulted in SI values of 5.28, 8.22, and 9.02, in the 10, 25, and 50% dose group, respectively. An estimated EC3 value was determined by means of extrapolation from the two lowest test item concentrations and their respective Stimulation Indices. This extrapolated EC3 value was calculated as 4.8% (w/w). The substance is therefore considered a skin sensitiser category 1B.
Based on the available information, the substance should be classified as sensitising to the skin in accordance with the criteria outlined in the EU CLP Regulation (1272/2008/EC and its amendments) resulting in Skin Sens. 1B / H317: May cause an allergic skin reaction.
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