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EC number: 941-129-0 | CAS number: 1407974-32-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 December 2013 to 21 December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Adequate in vivo testing carried out for US regulation, hence no in vitro study is provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
- EC Number:
- 941-129-0
- Cas Number:
- 1407974-32-6
- Molecular formula:
- C15H28O7 - C25H46O7
- IUPAC Name:
- D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
- Test material form:
- liquid: viscous
- Details on test material:
- - Substance type: UVCB
- Physical state: viscous yellowish liquid
- Analytical purity: 100% as UVCB
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd. Hillcrest, Dodgeford Lane Belton, Loughborough Leics, LE12 9TE / UK
- Age at study initiation: 11 weeks
- Weight at study initiation: 1791 - 1967g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 11/13 provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum.
- Water (e.g. ad libitum): Community tap-water from Itingen ad libitumin water bottles.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours darkness.
IN-LIFE DATES: From: 10 December 2013 To: 21 December 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/animal - Duration of treatment / exposure:
- 4 Hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm2
- Type of wrap if used:adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer bandage wrapped around the trunk
SCORING SYSTEM:The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be “not irritating” to rabbit skin.
- Executive summary:
Introduction
The acute dermal irritation potential of the test item was investigated according to OECD test guideline No. 404, Commission Regulation (EC) No. 440/2008, B.4, Japanese MAFF 12-Nousan.8187 (2000) and EPA OPPTS 870.2400 (1998).
Method
The test item was applied by topical semi-occlusive application of 0.5 mL to the intact skin of the left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated separately for each animal across 3 scoring times (24, 48 and 72 hours after patch removal) for erythema/eschar grades and for oedema grades, respectively.
Results
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0. The test item did not cause any staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. The test item is considered to be “not irritating” to rabbit skin.
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