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Diss Factsheets
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EC number: 939-238-3 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-08-20 to 1990-08-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Stearic acid, esters with methyl α-D-glucoside
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Stearic acid, esters with methyl α-D-glucoside
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, SsniffMÜZ (Alleindiät für Zuchtkaninchen), Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany
- Water: ad libitum, drinking water as for human consumption
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 50 - 85 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- The test article was applied undiluted.
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- 24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. In each animal, 0.5 ml of the test article were applied to the test site (ca. 6 cm2 in size)
- Area of exposure: back, 6 cm2 in size
- Type of wrap if used: semi-occlusive dressing consisting of Kosmoplast (Medilog), which was held in place by non-irritating tape Elastoplast (Beiersdorf AG, Hamburg), and Stülpa (Hartmann AG, Heidenheim/Brenz).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, any residual sample was washed away with water or an appropriate solvent.
- Time after start of exposure: after 4 h
SCORING SYSTEM:
- Dermal irritation was graded according to the EEC directive 83/467/EEC from July 29, 1983 and to GefStoffV, 1987(BGBI. I. p. 2721), as stipulated by OECD TG 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - No erythema and edema reactions after 30-60 min, 24 , 48 and 72 hours on control and treated skin area.
- Other effects:
- - No effects
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Based on the results of this study the test substance Stearic acid, esters with methyl α-D-glucoside is not irritating to skin.
- Executive summary:
In a primary dermal irritation study according to OECD TG 404, three New Zealand Whiterabbits were dermally exposed to 0.5 ml of Stearic acid, esters with methyl α-D-glucoside, undiluted as delivered by the sponsor. The test substance was applied for 4 hours to intact shaved body surface areas under semi-occlusive dressing. Animals then were observed for 72 hours. Irritation was scored by the method described in OECD Guideline 404.
No erythema and edema was observed after 30-60 min, 24, 48 and 72 hours.
In this study Stearic acid, esters with methyl α-D-glucoside is not a dermal irritant.
Content of a.i. in Stearic acid, esters with methyl α-D-glucoside according to producer’s information: 100 %.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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