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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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- 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 cited by: CIR, 2011. Decyl Glucoside and Other Alkyl Glucosides as Used in Cosmetics. 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:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Using non-occlusive applications, 2 mL of 0, 0.06, 0.18, or 0.54 g a.i./kg caprylyl/capryl glucoside (60% active) in distilled water (corresponding to concentrations of 0, 3, 9, and 27% a.i., respectively) were applied to the intact skin of the backs of 6 male rabbits/group.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- caprylyl/capryl glucoside
- IUPAC Name:
- caprylyl/capryl glucoside
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Type of coverage:
- other: non-occlusive
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
60 mg/kg bw/day
Basis:
nominal per unit area
- Remarks:
- Doses / Concentrations:
180 mg/kg bw/day
Basis:
nominal per unit area
- Remarks:
- Doses / Concentrations:
540 mg/kg bw/day
Basis:
nominal per unit area
- No. of animals per sex per dose:
- 6 males per group
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- slight to moderate
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decrease
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- not statistically significative decrease in testes weight
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- epithelial hyperplasia, hyperkeratosis, congestion, and eschar formation were observed in the skin of rabbits of the high dose group. No test article-related microscopic changes were observed in the testes or accessory sex glands at any dose.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 180 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: Decrease in body and testes weight, not statistically significative.
- Dose descriptor:
- LOAEL
- Effect level:
- 60 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: Slight to moderate dermal irritation.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In the main study, treatment-related signs of toxicity were not observed. 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 microscopic 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.
- Executive summary:
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.
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