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Diss Factsheets
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EC number: - | 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- of 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries. Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sprague Dawley rats, strain: Crl:CD(SD) with appropriate range of bodyweight at study start.
- Source: Charles River (UK) Ltd.
- Age at study start (day of dosing): 8 to 12 weeks.
- Weight at start (day of dosing): Females: minimum 232 g, maximum 255 g.
- Fasting period: Overnight immediately prior to dosing until ca. 4 hours post administration.
- Housing: In groups of 3 by sex in solid bottomed polycarbonate cages inside a barriered rodent facility.
- Bedding material: Autoclaved wood flake bedding
- Cage enrichment: Soft white chew block and plastic shelter (chew block removed during fasting).
- Diet: Standard rodent diet (Rat and Mouse No. 1 Maintenance Diet)
containing no added antibiotic, chemotherapeutic or prophylactic agent.
- Drinking water (ad libitum): Pottable drinking water from the public supply
- Acclimation period: At least 6 days before dosing.
Routine analysis of the batch of diet used, water and chew blocks did not provide evidence of contamination that might have prejudiced the study.
ENVIRONMENTAL CONDITIONS
Air conditioned room kept at positve pressure without re-circulation of the filtered fresh air supplied to the room.
Controlled environment, environmental conditions were set at:
- Temperature (°C): 21 ± 2°C
- Relative Humidity (%): 40 to 70%
- Photoperiod (artificial lighting): 12 hrs day / 12 hrs night
- Rate of air exchange: Ca. 15 changes/h
There were no deviations from these ranges, which compromised the quality, integrity or outcome of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methylcellulose
- Details on oral exposure:
- DOSE FORMULATION AND DOSE VOLUME:
- Concentration of test material in vehicle: 200 mg/mL
- Amount (dose volume by gavage): 10 mL/kg bw
Preparation of the test material formulation was on the day of dosing. Formulations were stirred before and throughout the dosing procedure.
ACUTE TOXIC CLASS METHOD - Rationale for the selection of the starting dose:
The starting dose of 2000 mg/kg was chosen based on information provided by the Sponsor. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (females only)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration on Day 1: 14 days (Days 1 to 15)
- Frequency of observations and weighing:
Mortality checks: At least twice daily.
Observation of clinical signs: Ca. 3 minutes post dosing and at frequent intervals thereafter on Day 1; subsequently twice daily and on Day 15 in the morning
Weighing of each animal: Day 1 prior to dosing and on Days 8 and 15.
- Necropsy performed: Yes, of all animals. - Statistics:
- Not applicable, as there were no deaths and only one dose group. In addition, the acute toxic class method is not intended for 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
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at 2000 mg/kg bw
- Mortality:
- Dose level Mortality
2000 mg/kg 0/3 (f)
2000 mg/kg 0/3 (f) - Clinical signs:
- Clinical signs were not evident.
- Body weight:
- No adverse effects on body weight.
- Gross pathology:
- Necropsy of each animal at the end of the 14-day post treatment observation period (Day 15) did not reveal any macroscopic pathology abnormalities.
Applicant's summary and conclusion
- Conclusions:
- In view of the oral LD50 > 2000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any labelling regarding acute oral toxicity according to EU regulations (REGULATION (EC) 1272/2008).
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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