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EC number: 940-678-3 | CAS number: -
Available literature data regarding the group of alkyl polyglucosides permitted to evaluate the long-term effects produced by "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite". More in details, an oral subchronic repeated toxicity study, an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening test and a dermal subacute repeated toxicity study were available and permitted to use the effect level values in the derivation of the no-effect levels (see DNEL Section). No inhalation repeated toxicity study is available because the exposure to "SSulfonation products of disodium sulfite with (esterification products of C10-16 (even numbered) Alkyl Polyglycosides with maleic anhydride)" through the inhalation route was considered not significant.
Sprague-Dawley rats were dosed by gavage with 0, 250, 500 and 1000 mg/kg bw/day C12/16 APG for 90 days. An additional 5 male and 5 female control and high dose rats were used as a recovery group. There were two fatalities, neither of which was linked to the test material. No treatment-related changes in body weights, organ weights, or biochemistry or hematology parameters were observed. Absolute gonad weights were decreased in all test groups, but the decrease was not considered treatment related by the researchers because of a lack of a dose-response. A dose-dependent, slowly reversible, irritation and ulceration of the forestomach mucosa was observed in animals of the 0.5 and 1 g/kg bw groups. Systemic toxicity was not observed in any group. The NOAEL for systemic toxicity was 1000 mg/kg bw. The NOEC for “local compatibility” (irritation and ulceration of the mucous membrane of the forestomach) was deduced as 2.5% active ingredient.
In a 14 -day study, using non-occlusive applications, 2 mL of 0, 60, 180, or 540 g active ingredient/kg caprylyl/capryl
glucoside (60% active) in distilled water were applied to the intact skin of the backs of 6 male rabbits/group. Slight dermal irritation was observed in all groups after the initiation of dosing; the irritation became moderate in the high dose group after 3 days of dosing. Microscopically, epithelial hyperplasia, hyperkeratosis, congestion, and eschar formation were observed in the skin of rabbits of the high dose group; these changes were not observed in rabbits of the other test groups. Body weights of rabbits of the high dose group were slightly, but significantly, decreased compared to controls. Absolute testes weights were slightly, but not significantly, decreased in the high dose group. Microscopically, no test article-related changes were observed in the testes or accessory sex glands at any dose.
No treatment-related effects on hematology or clinical chemistry values or organ weights were reported. The NOEL for systemic toxicity was 0.18 g a.i./kg caprylyl/capryl glucoside.
In the oral repeated toxicity studies, no systemic effects were observed after the administration of the substance, therefore the NOAEL was set at the highest dose tested (1000 mg/kg bw/day). Locally, instead, oedema and ulceration of the forestomach were noted in the highest dose group.
In the dermal repeated toxicity study, no significative systemic effects were observed, with the exception of a slight decrease in body weights. The NOAEL for systemic toxicity was set at 180 mg/kg bw/day. Locally, instead, slight dermal irritation was noted in all dosage groups, but it became moderate in the highest dose-group after 3 days treatment. The LOAEL for local effects was evaluated to be 60 mg/kg bw/day (1.18 mg/cm3).
No severe systemic effects were observed, neither in the oral repeated toxicity study, nor in the dermal repeated toxicity study.
Local effects produced by group of alkyl polyglucosides were coherent with the classification of "Sulfonation products of disodium sulfite with (esterification products of C10-16 (even numbered) Alkyl Polyglycosides with maleic anhydride)" for acute effects. Indeed skin irritation resulted to be slight, while irritation of mucose membrane produced slowly reversible effects, as for acute eye exposure.
Results of repeated toxicity studies did not lead to the classification of "Sulfonation products of disodium sulfite with (esterification products of C10-16 (even numbered) Alkyl Polyglycosides with maleic anhydride)" for long term effects.
Specific Target Organ Toxicity after Repeated Exposure:
Classification: not required
Signal word: none
Hazard statement: none
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