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EC number: 943-980-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- other: ReadAcross
- Remarks:
- The end point is covered by test carried out on another AlkylPolyGlucoside esters considering the similar structure and a number of cross experiments which shown a similar behaviour. A rationale is available on it
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is cited by CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosemtics. Final Safety Assessment.
- Justification for type of information:
- The end point is covered by test carried out on another AlkylPolyGlucoside esters considering the similar structure and a number of cross experiments which shown a similar behaviour. A rationale is available on it
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- 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.
- Endpoint conclusion:
- no study available
- Endpoint conclusion:
- no study available
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 180 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 1.18 mg/cm²
- Study duration:
- subacute
- Species:
- rabbit
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.
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.
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""Sodium salt of esterification products of C10-C16 (even numbered) alkylpolyglycosides with citric acid" 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 ""Sodium salt of esterification products of C10-C16 (even numbered) alkylpolyglycosides with citric acid" for long term effects.
Specific Target Organ Toxicity after Repeated Exposure:
Classification: not required
Signal word: none
Hazard statement: none
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Ecology and Toxicology of Alkyl Polyglucosides
- Author:
- Willing A, Messinger H and Aulmann W
- Year:
- 2 004
- Bibliographic source:
- CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosemtics. Final Safety Assessment.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- C12/16 Alkyl Polyglucoside
- IUPAC Name:
- C12/16 Alkyl Polyglucoside
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Main experiment: 10 males and 10 females.
Control: 5 males and 5 females.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
250 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
500 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Main experiment: 10 males and 10 females.
Control: 5 males and 5 females. - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Animal were subjected to routine clinical observations. Their body weight and food and water consumption were recorded. Haematologicalm clinicochemical and ophtalmoscopic investigations were performedduring week 7 and 13. At the end of the treatment period, all the animals were subjected to general pathological examination and organ weight analizes. A wide range of tissues was fixed and examineted by microscope.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 2 mortalities.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 2 mortalities.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- ulcers and oedema confined to the forestomach of the highest dose level.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- slowly reversible, dose-related irritation and ulceration of the mucous membrane of the forestomach of animals in the highest dose group.
- Histopathological findings: neoplastic:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: irritation and ulcers in the forestomach
- Key result
- Dose descriptor:
- other: NOAEC
- Effect level:
- 2.5 other: %
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: irritation and ulcers in the forestomach
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Systemic toxicity was not observed in any group. The NOAEL for systemic toxicity was 1000 mg/kg bw/day. The NOEC for “local compatibility” (irritation and ulceration of the mucous membrane of the forestomach) was deduced as 2.5% active ingredient.
- Executive summary:
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.
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