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EC number: 274-434-6 | CAS number: 70210-37-6
- 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 LD50 in rats > 15000 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test parameters documented do not totally comply with a testing guideline but they are sufficient to accept the data, even if pathology was not performed.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- In order to determine the dose/response relationship of the test substance, groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 g
- Housing: housed in groups of 5 in macrolon cages (Size3)
- Fasting period before study: animals having been fasted overnight
- Diet and water: animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.
- Acclimation period: acclimatized in laboratories for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12-hour light period - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Concentration in vehicle: 10 % or 50 %
- Doses:
- 1000, 3000, 10000 and 15000 mg/kg bw
- No. of animals per sex per dose:
- Groups of 5 male and 5 female rats
- Control animals:
- no
- Details on study design:
- Symptoms and mortality after administration were recorded during an observation period of 8 days.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed up to the dose of 15000 mg/kg bw
- Clinical signs:
- other: No symptoms at doses of 1000 to 3000 mg/kg . Reduction of spontaneous motility was observed after 3 hours after dose administration of 10000 mg/kg . No symptoms have not been recorded after 24 hours. At the dose of 15000 mg/kg, reduction of spontaneous mo
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test substance was practically devoid of toxicity at each dose level.
The acute oral LD50 in rats was established to be > 15000 mg/kg bw. - Executive summary:
The oral acute toxicity study was performed according to an internal method: groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.
The acute oral LD50 in rats was established to be > 15000 mg/kg bw.
Reference
Route of admin. | Dose mg/kg | Vehicle | Concentration (%) | Mortality | Bodyweight (g) | Symptoms | ||||
male | female | % | Day of test | pre-test | day 8 of test | |||||
p.o. | 1000 | dist. water | 10 | 0/5 | 0/5 | 0 | - | 100 | 170 | none |
p.o. | 3000 | dist. water | 10 | 0/5 | 0/5 | 0 | - | 100 | 171 | none |
p.o. | 10000 | dist. water | 50 | 0/5 | 0/5 | 0 | - | 100 | 168 | reduction in spontaneous motility > 3 hours After 24 hours, no symptoms |
p.o. | 15000 | dist. water | 50 | 0/5 | 0/5 | 0 | - | 100 | 157 | ditto, hypoventilation, slight ataxia |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 000 mg/kg bw
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
Despite the key study was not carried out according to a OECD Guideline, but to an internal method, the test turns out to be sufficiently detailed (even if pathology was not performed). Groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.
The acute oral LD50 in rats was established to be greater than 15000 mg/kg.
Justification for selection of acute toxicity – oral endpoint
The test results/procedures described do not totally comply with a testing guideline (OECD 401) but they are sufficient in quantity and quality to permit an evaluation of the effects of the test substance.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:
- category 1: ATE ≤ 5 mg/kg bw
- category 2: 5 < ATE ≤ 50 mg/kg bw
- category 3: 50 < ATE ≤ 300 mg/kg bw
- category 4: 300 < ATE ≤ 2000 mg/kg bw
The acute oral LD50 in rats was established to be greater than 15000 mg/kg bw.
Therefore, the substance is not classified for oral acute toxicity according to the CLP Regulation (EC n. 1272/2008).
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