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EC number: 433-100-1 | 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
The acute oral median lethal dose (LD50) of the test substance (EC: 433-100-1) was found to be greater than 2000 mg/kg bw.
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:
- 1999-01-10 to 1999-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 96/54 EWG B.1.tris (Akute-toxische-Directive 96/54 EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 22. March 1996
- 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
- Starin: HsdBrl:WH,Full-Barrier
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Female 150 - 162 g; male 146 - 153 g
- Fasting period before study: Animals were fasted by withholding food over-night. Following the period of fasting the animals were weighed and the test substance was administered. Then the food was withhold for a further 3-4 hours.
- Housing: Individually kept in Macrolon cages on Altromin saw fiber bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water: ad libitum, tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3° C
- Humidity: 55 ± 10%
- Air changes: 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.00 - 18.00 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Carboxymethylcellulose (1 % in aqua dest.)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: Carboxymethylcellulose; 1% in aqua bidest.
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males/3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, cageside observations, respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern, observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - 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.
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material (EC: 433-100-1) in the Wistar rat (HsdBrl strain) was found to be greater than 2000 mg/kg bw.
- Executive summary:
The test substance (EC: 433-100-1) was tested for acute toxicity on oral administration in rats in a study according to EU Method B.1/OECD Guideline 423. A single dose of 2000 mg/kg bw was administered by oral gavage to 3 male and 3 female Wistar rats. The animals were observed for fourteen days for signs of toxicity. No signs of mortality or systemic toxicity were noted during the study. All animals showed an expected gain in body weight during the study. No abnormalities were noted at necropsy.
Therefore, the acute oral median lethal dose (LD50) of the test substance (EC: 433-100-1) was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- EU Method B.1/OECD Guideline 423 (RL1)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral
The test substance (EC: 433-100-1) was tested for acute toxicity on oral administration in rats in a study according to EU Method B.1/OECD Guideline 423. A single dose of 2000 mg/kg bw was administered by oral gavage to 3 male and 3 female Wistar rats. The animals were observed for fourteen days for signs of toxicity. No signs of mortality or systemic toxicity were noted during the study. All animals showed an expected gain in body weight during the study. No abnormalities were noted at necropsy. Therefore, the acute oral median lethal dose (LD50) of the test substance (EC: 433-100-1) was found to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.
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