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EC number: 947-854-9 | 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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 401), rat: > 2000 mg/kg bw (limit test)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 May - 22 May 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted Feb 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Commission Directive No 92/69/EEC of July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe: W1SKf(SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, Germany; SPF breeding colony
- Age at study initiation: 6 - 8 weeks (males) and 7 - 10 weeks (females)
- Weight at study initiation: 163 - 175 g (males) and 162 - 173 g (females)
- Fasting period before study: from 16 h before to 3 - 4 h after treatment
- Housing: in groups of 5 animals in macrolon cages (type 4) on soft wood granulate
- Diet: ssnitt® R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle: 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs twice a day (in the morning and in the afternoon), on weekends and public holidays only once. Body weights were determined weekly.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Gross pathology revealed no substance-related findings.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study a LD50 value of > 2000 mg/kg bw was derived in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 1) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 (Jensch, 1996), conducted in compliance with GLP. The test substance was applied via gavage as 10% dilution in deionized water. A dose of 2000 mg/kg bw (limit test) test substance was administered to 5 male and 5 female rats. Animals were observed for mortality and general clinical condition twice daily for 14 days. Body weights were recorded on the day of administration (Day 1) and on Days 8 and 15 thereafter. Macroscopic examination was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. No pathological findings were observed at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats.
In a supporting study, the acute oral toxicity was assessed in a study equivalent to OECD Guideline 401 with limited documentation (Bouffechoux, 1995). A single oral dose of 2000 mg/kg bw (limit test) was given to 5 female Swiss mice. Animals were observed for mortality, body weight, general clinical signs and behavior for 14 days. None of the animals died and no clinical symptoms or changes in behavior were observed during the study. The body weight gain was not affected by the administration of the test substance. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats. This study was not taken into account for hazard assessment.
Justification for classification or non-classification
The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification
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.
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