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EC number: 202-571-3 | CAS number: 97-30-3
- 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
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- Flash point
- Auto flammability
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- 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
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-08-01 to 2008-08-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Notification No. 8147, Nov. 2000
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young adult animals (approx. 9-12 weeks old)
- Weight at study initiation: 165 - 200 g
- Fasting period before study: max 20 h, 3- 4 hours after administration
- Housing: group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.)
- Diet: ad libitum, pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ±3.0°C (actual range: 19.7 - 21.5°C)
- Humidity (%):30-70% (actual range: 47 - 82%)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% aq. carboxymethyl cellulose and water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 % aqueous carboxymethyl cellulose
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 300 mg/kg bw. In a stepwise procedure additional groups of females were dosed at 300 and 2000 mg/kg bw.
- Frequency of dosage: single dosage, on day 1
- Duration of observation period following administration: 15 days
- Frequency of observations (mortaliity/viability): twice daily
- Frequency of weighing: day 1 (pre-administration), 8 and 15
- Frequency of observation (clinical signs): at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15
- Necropsy of survivors performed: yes
- Clinical signs: The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1). - Statistics:
- - No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- - No mortality occurred.
- Clinical signs:
- other: - Hunched posture and/or piloerection were noted in all animals on day 1 and in the first set of animals at 300 mg/kg bw on day 2.
- Gross pathology:
- - No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of test substance in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study according to OECD TG 423, groups of fasted, young adult female Wistar rats were given a single oral dose of test substance Isostearic acid, esters with methyl α-D-glucoside in 1% aq. carboxymethyl cellulose and water. The substance was administered by oral gavage at 300 mg/kg bw. In a stepwise procedure additional groups of females were dosed at 300 and 2000 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.
Oral LD50 Females > 2000 mg/kg bw
No mortality occurred. Hunched posture and/or piloerection were noted in all animals on day 1 and in the first set of animals at 300 mg/kg bw on day 2. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
In this study Isostearic acid, esters with methyl α-D-glucoside in 1% aq. carboxymethyl cellulose and water is practically non-toxic based on LD50 in female rats.
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