Mexoryl SX is intended for use in sunscreens and moisturisers and, as such, be expected to be released to the environment via consumer use through washing the residual chemical (assumed to be 100% of that applied) off the skin and into the sewerage system. The ready biodegradability of the notified chemical was assessed by the 'Closed Bottle' method (OECD TG 301D). Sealed bottles containing the test substance (2.2 mg/L) and inorganic medium were inoculated with activated sewage sludge bacteria and incubated for 28 days. The notified chemical attained 41% biodegradation after 28 days. Therefore, it may not strictly be termed as readily biodegradable, although its inherent biodegradability is uncertain. No bioaccumulation of the chemical is expected because its very high water solubility and low octanol/water partition coefficient. 9. EVALUATION OF TOXICOLOGICAL DATA 9.1 Acute Toxicity The submission for Mexoryl SX Active Ingredient is a limited submission as no more than 1 000kg of the notified chemical will be imported annually, as such, there is no requirement to submit toxicological data. However, the notifier has submitted an extensive range of toxicological information which is discussed below. Summary of the toxicity of Mexoryl SX Active Ingredient Test Species Outcome Reference oral toxicity rat LD50 > 1 835 mg/kg #5 *acute dermal rat LD50 > 1 637 mg/kg #7 toxicity *skin irritation rabbit non-irritant #8 **eye irritation rabbit corrosive/slight #10 irritant (see text) skin sensitisation guinea pig nonsensitising #13 *acid (36.7% aqueous solution) ** triethanolamine salt # only summaries sighted 9.1.1 Oral Toxicity (#5) Species/strain: Sprague-Dawley rats 5/5 Number/sex of animals, M/F: Observation period: not stated Method of administration: aqueous solution (acid, 36.7% active material), single oral dose
Mexoryl SX is intended for use in sunscreens and moisturisers and, as such, be expected to be released to the environment via consumer use through washing the residual chemical (assumed to be 100% of that applied) off the skin and into the sewerage system. The ready biodegradability of the notified chemical was assessed by the 'Closed Bottle' method (OECD TG 301D). Sealed bottles containing the test substance (2.2 mg/L) and inorganic medium were inoculated with activated sewage sludge bacteria and incubated for 28 days. The notified chemical attained 41% biodegradation after 28 days. Therefore, it may not strictly be termed as readily biodegradable, although its inherent biodegradability is uncertain. No bioaccumulation of the chemical is expected because its very high water solubility and low octanol/water partition coefficient. 9. EVALUATION OF TOXICOLOGICAL DATA 9.1 Acute Toxicity The submission for Mexoryl SX Active Ingredient is a limited submission as no more than 1 000kg of the notified chemical will be imported annually, as such, there is no requirement to submit toxicological data. However, the notifier has submitted an extensive range of toxicological information which is discussed below. Summary of the toxicity of Mexoryl SX Active Ingredient Test Species Outcome Reference oral toxicity rat LD50 > 1 835 mg/kg #5 *acute dermal toxicity rat LD50 > 1 637 mg/kg #7 *skin irritation rabbit non-irritant #8 **eye irritation rabbit corrosive/slight irritant (see text) #10 skin sensitisation guinea pig nonsensitising #13 *acid (36.7% aqueous solution) ** triethanolamine salt # only summaries sighted 9.1.1 Oral Toxicity (#5) Species/strain: Sprague-Dawley rats Number/sex of animals, M/F: 5/5 Observation period: not stated Method of administration: aqueous solution (acid, 36.7% active material), single oral dose