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EC number: 224-632-3 | CAS number: 4432-31-9
- 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
In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form (CAS 4432-31-9).
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:
- 2016-10-4 to 2016-10-20
- 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)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 187 - 192 g (1st step), 185-190 g (2nd step)
- Fasting period before study: 1 day
- Housing: group caging (3 rats/cage), Type II polypropylene/polycarbonate
- Diet: ad libitum, ssniff® SM R/M-Z+H complete diet for rats and mice
- Water: ad libitum, tap water
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle
- Purity: aqua purificata Ph.Hg. VIII. from Parma Produkt Kft. (Batch no. 1606-5508)
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD
- Rationale for the selection of the starting dose: Selection was based on the basis of the available information about the test item and similar substances. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed at least once daily and weighted on days 0, 7 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, appearance of tissue and organs
- experimental design: the study was performed in two consecutive steps with three rats per step. - Statistics:
- not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- moderate to severe hydrometra, a physiological finding related to the cycle of the rats, was observed in two rats
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test substance is considered to be >2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423. The study was conducted in two consecutive steps with three rats per step. All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period. No signs of toxicity were detected. The body weight development was normal. Gross pathology showed no test substance related alterations. The LD50 value of the test substance is considered to be >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:
- OECD TG 423, GLP
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- 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
- Justification for type of information:
- According to (EC) No 1907/2006, Annex VIII, 8.5, column 2, at least one other route for substances shall be tested for acute toxicity in addition to the oral route. However, due to the estimated very low vapour pressure (1.39e-4 Pa) of the substance, exposure of humans via inhalation of vapours is unlikely. No adverse effects have been observed (i) in an acute oral toxicity study at a limit dose of 2000 mg/kg bw and (ii) in a combined repeated dose up to the highest dose tested. Therefore, although the test material is a solid powder and exposure to dusts are possible, no adverse effects are expected and no additional study on acute inhalation toxicity was performed.
- Clinical signs:
- other:
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)
- Justification for type of information:
- According to (EC) No 1907/2006, Annex VIII, 8.5, column 2, at least one other route for substances shall be tested for acute toxicity in addition to the oral route. Since dermal absorption will be very low and no effects have been reported in an in vivo skin sensitisation study, a study on acute dermal toxicity was waived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral
The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423. The study was conducted in two consecutive steps with three rats per step. All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period. No signs of toxicity were detected. The body weight development was normal. Gross pathology showed no test substance related alterations. The LD50 value of the test substance is considered to be >2000 mg/kg bw. The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form (CAS 4432-31-9).
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for acute oral toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.
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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