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EC number: 473-310-0 | CAS number: 478385-88-5
- 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
Acute oral Toxicity, rat, LD50 > 2000 mg/kg bw/d (reference (7.2.1 -1).
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:
- June 26 - July 11 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation: m: 183 - 198 g ; f: 163 - 170 g
- Fasting period before study: Diet was withheld from 17 hours before until up to 4 hours after treatment.
- Housing: The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate. The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23 °C
- Humidity: 45 - 65 %
- Air changes not specified, but air conditioned
- Photoperiod: 12 / 12 hrs dark / hrs light
According to the specifications given by the manufacturer, the diet, Provimi Kliba 3433.0, had been checked by independent laboratories. Analysis included qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. The drinking water was periodically analyzed according to the regulations for human drinking water. The softwood granulate was analytically checked by independent laboratories. - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Methocel K4M Premium solution
- Doses:
- 2000 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 3 (m) / 3 (f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part. The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.
- Necropsy of survivors performed: yes: All rats were sacrificed at the end of the experimental part by CO2-asphyxia. They were subjected to a gross pathological investigation. - Statistics:
- The body weight data were recorded with a PC-program. The statistical evaluations of the body weight were carried out with a PC-program. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed. All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test material.
- Gross pathology:
- At necropsy no organ alterations were seen.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded, that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats.
- Executive summary:
The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man. The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.
This study was performed according to the "Acute toxic class method" (ATC). No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the result of this study, it is concluded that the test material has no relevant acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
Reference
No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test material.
All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline conform study.
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
Acute oral toxicity in the rat (reference 7.2.1 -1)
The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man. The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC). No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the result of this study, it is concluded that the test material has no relevant acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute oral toxicity, the test item does not require
classification as acutely toxic after oral administration according to
Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in
Regulation (EU) 2019/521.
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