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Diss Factsheets
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EC number: 406-077-0 | 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
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:
- From February 13, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- - Lot No.: LAB.J.-NO.: 6107/1427
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animal breeder: dr. K Thomae GMBH, Biberach
Acclimatization period: at least one week
Number of animals per dose: 5 males/ 5 females
Type of cage: stainless steel wire mesh cages, type DK-III
Bedding: no bedding in the cages, sawdust in the waste trays
No. of animals per cage: 5
Identification: using cage cards and tails marking
Room temperature/relative humidity: the animals were housed in fully air-conditioned rooms, 20 -24 °C and 30-70 % of relative humidity.
Day/night rhythm: 12/12
Drinking water: ad libitum per day
Diet: Kliba-labordiaest 343
Food and water was assayed for contaminants
Animal weights: young adult animals of comparable weight
Fasting period: the animals were given no feed about 16 hours before administration but water was available ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- other: aqua dest.
- Details on oral exposure:
- Route of administration: single oral administration by gavage
Test substance formulation with aqua dest.
Form of administration: suspension - Doses:
- Reason for the doses: based on the chemical and physical characteristic of the test substance no pronounced acute oral toxicity was expected, therefore the following dose has been chosen for the study: 2200 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- Observations: Signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Pathology: Withdrawal of food about 16 h before sacrifice with CO2, then necropsy with gross-pathological examination. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Gross pathology:
- No pathologic findings noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401, in compliance with GLP. Groups of 5 females and 5 males were dosed by gavage with the test substance suspended in aqua dest at a single limit dose of 2200 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. Upon completion of the study, the stability of the substance was analytically verified. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. The results of the chemical analysis confirmed the top dose to be 27.1 g/100 ml, 23% higher than the nominal value. Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw (Kirsch, 1990).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989/90
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- to form a paste
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no animal died
- Clinical signs:
- other: no effects
- Gross pathology:
- no effects
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
A study was conducted to determine the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401, in compliance with GLP. Groups of 5 females and 5 males were dosed by gavage with the test substance suspended in aqua dest at a single limit dose of 2200 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. Upon completion of the study, the stability of the substance was analytically verified. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. The results of the chemical analysis confirmed the top dose to be 27.1 g/100 ml, 23% higher than the nominal value. Under the study conditions, the acute oral LD50 of the test substance in Wistar rat was >2200 mg/kg bw (Kirsch, 1990).
A study was conducted to determine the acute dermal toxicity of the test substance in Wistar rats according to OECD Guideline 402, in compliance with GLP. The test substance was applied to the intact skin of 5 female and 5 male rats at a single limit dose of 2000 mg/kg bw. The rats were then observed for 14 d for mortality, clinical signs and bodyweight changes. There was no mortality and no evident signs of toxicity or bodyweight loss were observed. Under the study conditions, the acute dermal LD50 of the test substance in Wistar rat was >2000 mg/kg bw (Kirsch, 1990).
Justification for classification or non-classification
Based on the results of acute toxicity studies in rats, the substance does not require classification for this endpoint according to CLP (EC 1272/2008) criteria.
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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