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EC number: 274-492-2 | CAS number: 70236-62-3
- 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
LD50 (male/female)= 5437 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:
- comparable to guideline study with acceptable restrictions
- 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 carboxymethylcellulose by oral intubation. Symptoms and mortality after administration were recorded during an observation period of 14 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
- Age: 6 o 7 weeks
- Weight at study initiation: 160 g to 180 g
- Housing: housed in groups of 5 in macrolon cages (Size 3)
- Fasting period before study: animals were starved during one night before starting the treatment
- Diet and water: animals were fed a standard diet of Nafag ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: approximately 50 % - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2 %
- Details on oral exposure:
- - Concentration in vehicle: 30 % or 40 %
- Doses:
- 2780, 4640, 6000, 7750 and 10000 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 14 days.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 437 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 4 715 - < 6 270
- Mortality:
- Mortality was observed starting from the dose of 4640 mg/kg bw at 24 hours.
- Clinical signs:
- Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position, diarrhoea and ruffled fur. Sedation, diarrhoea and ruffled fur became more accentuated as the dose was increased.
- Gross pathology:
- No substance related gross organ changes were seen in the killed animals.
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Conclusions:
- The acute oral LD50 of the susubstance in rats of both sexes observed over a period of 14 days is 5437 (4715-6270) 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 carboxymethylcellulose by oral intubation. Symptoms and mortality after administration were recorded during an observation period of 14 days.
The acute oral LD50 of the substance in rats of both sexes observed over a period of 14 days is 5437 (4715-6270) mg/kg bw.
Reference
Dose (mg/kg) | Concentration (%) of formulation | Number of animals | Died within | ||||||||||
1 hr | 24 hrs | 48 hrs | 7 days | 14 days | |||||||||
Male | Female | Male | Female | Male | Female | Male | Female | Male | Female | Male | Female | ||
2780 | 30 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4640 | 40 | 5 | 5 | 0 | 0 | 1 | 0 | 2 | 1 | 2 | 2 | 2 | 2 |
6000 | 40 | 5 | 5 | 0 | 0 | 1 | 3 | 1 | 4 | 1 | 4 | 1 | 4 |
7750 | 40 | 5 | 5 | 0 | 0 | 2 | 5 | 2 | 5 | 4 | 5 | 4 | 5 |
10000 | 40 | 5 | 5 | 0 | 0 | 4 | 4 | 5 | 5 | 5 | 5 | 5 | 5 |
The LD50 was calculated by probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 437 mg/kg bw
- Quality of whole database:
- The test results/procedures cannot be subsumed under a testing guideline, but they are nevertheless well documented and scientifically acceptable.
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. Groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in carboxymethylcellulose administered by oral intubation. Symptoms and mortality after administration were recorded during an observation period of 8 days.
The acute oral LD50 in rats was established to be 5437 mg/kg bw.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 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 5437 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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