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Diss Factsheets
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EC number: 432-070-7 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1998 - September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- none
Constituent 1
Test animals
- Species:
- other: rat, Wistar Crl:WI BR (SPF)
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35-42 days
- Weight at study initiation:
males: 225.4 g +/- 5.1g; n=5
females: 175.2 g+/- 1.5 g; n=5
- Fasting period before study:
- Housing: Altromin Type S8/15; granulated soft wood bedding
- Diet: (ad libitum): Altromin 1326, pellet standard diet, batch# 140698/1206
- Water (ad libitum): tap water (municipal supply), Makrolon bottles, changed daily
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 50-70 %
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a ccle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 6g ad. 30 ml
- Amount of vehicle (if gavage): 6g ad. 30 ml
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight - Doses:
- 2,000 mg/kg body weight (b.w) using 5 males and 5 females. Individual doses were adjusted according to the body weight on the day of administration.
- No. of animals per sex per dose:
- 2,000 mg/kg body weight (b.w) using 5 males and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation period all animals were killed by chloroform inhalation. All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined macroscopically. - Statistics:
- body weights: Calculation of group mean values and standard deviations.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels: On the day of administration of the test article a slight apathy was observed in all animals and a slight squatting position was shortly observed in one male and in two female animals. None of the animals showed furhter alterations of their general state of well-being and behaviour.
- Body weight:
- The body weight gain was not affected.
- Gross pathology:
- No macroscopic pathological findings in the animals.
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is neither a toxic nor a harmful substance according to this acute oral toxicity study.
- Executive summary:
Acute oral toxicity of the test item was tested in male and female Charles River Wistar rats.
The test article was administered at a single dose of 2000 mg/kg body weight by gavage.
Animals were examined for mortality, clinical signs, body weight gain and pathological alterations of organs at the end of a 14-day observation period.
None of the animals died during the course of investigation.
On the day of administration of the test article a slight apathy was observed in all animalsand a slight squatting position was shortly observed in one male and in two female animals.
No pathological findings were observed at necropsy. The body weight gain was not affected.
The LD50 is > 2000 mg/kg body weight .
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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