Registration Dossier
Registration Dossier
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EC number: 946-764-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
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 " Sodium salt of esterification products of C10-C16 (even numbered) alkylpolyglycosides with citric acid" through the inhalation route was considered not significant.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The combined repeated dose toxicity study with reproduction/developmental toxicity screening test confirms the results of the read-across study.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 180 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 1.18 mg/cm²
- Study duration:
- subacute
- Species:
- rabbit
Additional information
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).
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
The study refers to the category of alkyl polyglucosides, and
"Sulfonation products of (esterification products of C9-11 (branched and
linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride)
with disodium sulfite" pertains to this group.
Justification for selection of repeated dose toxicity dermal -
systemic effects endpoint:
The study refers to the category of alkyl polyglucosides, and
"Sulfonation products of (esterification products of C9-11 (branched and
linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride)
with disodium sulfite" pertains to this group.
Justification for selection of repeated dose toxicity dermal - local
effects endpoint:
The study refers to the category of alkyl polyglucosides,
"Sulfonation products of (esterification products of C9-11 (branched and
linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride)
with disodium sulfite" pertains to this group.
Justification for classification or non-classification
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" Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt" for acute effects. Indeed skin irritation resulted to be slight like the irritation of mucose membrane, as for acute eye exposure.
Results of repeated toxicity studies did not lead to the classification of " Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt" for long term effects.
Specific Target Organ Toxicity after Repeated Exposure:
Classification: not required
Signal word: none
Hazard statement: none
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