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Diss Factsheets
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EC number: 700-680-5 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-08-19 to 2008-09-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August, 1988
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isostearic acid, esters with methyl α-D-glucoside
- EC Number:
- 700-680-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Isostearic 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
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: in controlled environment, individual cages with perforated floors (Scanbur, Denmark, dimensions: 56x44x37.5 cm)
- Diet: pelleted diet for rabbits (K-H from SSNIFF Spezialdiäten GmbH, Soest, Germany), approx 100 g/day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): The test substance was applied as delivered by the sponsor. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 animals
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit. The two others were treated in a similar manner 2 weeks later, after considering the degree of skin irritation observed in the first animal.
Approx. 24 h before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approx. 150 cm2 (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
TEST SITE
- Area of exposure: one flank, using a metalline patch 2x3 cm
- Type of wrap if used: The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned using tap water and watery ethanol (50 % v/v).
- Time after start of exposure: 4 h
OBSERVATION
- Mortality/Viability: twice daily
- Body weight: day of treatment (prior to application) and at termination
HISTOPATHOLOGY
- no histopathology was performed
SCORING SYSTEM:
Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness): 4 (Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the max. grade for erythema (=4) was given.
Oedema formation:
- No edema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well-defined by definite raising): 2
- Moderate oedema (raised approx. 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: scaliness on day 72h to 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal: # 2, 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal: # 1, 2, 3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight erythema in the treated skin areas of all three animals after 60 minutes, which had resolved within 24 h after exposure in two animals and within 7 days after exposure in one animal.
- Scaliness in the treated skin area of one animal was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.
- Dry remnants of the test substance were present on the skin of two animals on day 1.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
1/1b/1b |
0/0/0 |
24 h |
1/0/0 |
0/0/0 |
48 h |
1/0/0 |
0/0/0 |
72 h |
1c/0/0 |
0/0/0 |
7 d |
0c/-/- |
0/-/- |
14 d |
0/-/- |
0/-/- |
Average 24h, 48h, 72h (mean per animal) |
1/0/0 |
0/0/0 |
Reversibility*) |
c. |
c. |
Average time (unit) for reversion |
24 h |
- |
- First animal sentinel
*) Reversibility: c.= completely reversible, n.c.= not completely reversible; n.= not reversible
b) Dry remnants of the test substance present
c) Scaliness
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the results of this study the test substance is not irritating to the skin.
- Executive summary:
In a primary dermal irritation study according to OECD Guideline 404 three young adult male New Zealand White rabbits were dermally exposed to 0.5 g of Isostearic acid, esters with methyl α-D-glucoside as supplied by the sponsor for 4 hours, under semi-occlusive dressing. The animals then were observed for 14 days. Irritation was scored by the method described in OECD Guideline 404.
Very slight erythema in the treated skin areas of all three animals was observed after 60 minutes, which had resolved within 24 h after exposure in two animals and within 7 days after exposure in one animal. Scaliness in the treated skin area of one animal was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.
In this study Isostearic acid, esters with methyl α-D-glucoside is not a dermal irritant.
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