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EC number: 939-266-6 | CAS number: 1179883-13-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. No positive control was used to demonstrate the validity and reliability of the method.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control was used to demonstrate the validity and reliability of the method
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA method was not available at the timepoint of test duration.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 340 g
- Housing: animals were housed in groups of 2-3 in Makrolon Type IV cages with standard softwood bedding.
- Diet: pelleted Altromin Maintenance Diet 3022 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25% - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25% - No. of animals per dose:
- Range finding test: 3 (in test groups)
Main study: 10 (controls), 20 (in test groups) - Details on study design:
- RANGE FINDING TESTS: 3 animals were exposed to 6, 12.5, 25 and 50% of the test substance in distilled water for 6 h. After treatment, treated areas were rinsed with tap water. The highest, technically possible concentration of 50% test substance in distilled water did not produce any skin reactions in the animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: distilled water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Day 0-21
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (challenge and rechallenge)
- Day(s) of challenge: 28 (challenge) and 35 (rechallenge)
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: test substance in distilled water
- Site: bilaterally (left and right cranial flank)
- Concentrations: 50% (challenge) and 25% (rechallenge)
- Evaluation (hr after challenge): 6 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- rechallenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: rechallenge: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- rechallenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: rechallenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are limited data available on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).
One key study in guinea pigs on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) (30% C16/C18-APG and 70% C16/C18 fatty alcohols) according to the Buehler method (OECD guideline 406) is available (Henkel, 1993). In this GLP-study, 20 females were exposed to the test substance at a concentration of 50% in water during the induction phase. A control group was treated with the vehicle only. No skin sensitising effects were observed in any treated or control animals after treatment with the test substance at concentrations of 50% at challenge and 25% at rechallenge, respectively. Under the conditions of this study, the test substance was not considered to be a skin sensitiser.
Further studies are available for hexadecan-1-ol (CAS 36653-82-4), octadecan-1-ol (CAS 112-92-5), D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1), which support a non-sensitising potential of the substance to be registered.
The alcohols hexadecan-1-ol and octadecan-1-ol were tested under similar conditions in a GPMT according to OECD 406 and in compliance with GLP (SafePharm, 1996 a and b). In these experiments, guinea pigs were intradermally and epicutaneously induced with 1% and 50%, respectively, of the test substances in arachis oil and challenged with 25% or 50% of the test substance in arachis oil on respective flanks. No effects on skin were observed after treatment in any of the animals tested. Based on these results, hexadecan-1-ol and octadecan-1-ol were not sensitising to skin.
A GPMT with the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides according to OECD 406 is available (Henkel, 1988). The animals were induced intradermally and epicutaneously with 0.1% and 10%, respectively, of the test substance in propylene glycol. At the 24 and 48 h examination, slight irritation was provoked by the challenge treatment with the test substance at 1.25% in 1/20 of the animals of the control groups, but not in the treated groups. At 2.5% challenge concentration, slight erythema were apparent in 3/20 animals of controls and 1/20 of the test group animals at the 24 h reading. At the 48 h examination, slight erythema were observed in 1/20 animals of the control and treated group, respectively. Based on these results, D-Glucopyranose, oligomeric, C10-16-alkyl glycosides had no sensitising effect on guinea pigs under the chosen experimental conditions.
No effects on skin sensitisation were also reported in a LLNA assay with the category member Decyl octyl glycosides at concentrations of 1, 3 and 10%, respectively (Zeneca, 1993). However, documentation of that study was too limited for assessment.
Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising
Justification for selection of skin sensitisation endpoint:
There is only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) and for structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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