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EC number: 275-033-9 | CAS number: 70942-15-3
- 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(oral) = 5000 mg/kg bw; LC50(inhal) > 2.8 mg/l; LD50(ip) = 380 mg/kg bw.Acute intraperithoneal administration: LD50
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)
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 weeks
- Weight at study initiation: 192 g (♂) and 151 g (♀).
- Housing: Rats were caged singly
- Diet: A commercial pelleted diet ad libitum
- Water: ad libitum
- Fasting period before study: 18 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: a 25 % (w/v) suspension of the compound in tap water. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Deaths and clinical symptoms wars recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the 14 day observation period.
- Clinical signs:
- other: No clinical symptoms were recorded
- Gross pathology:
- At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- LD50(male/female) > 5000 mg/kg bw
- Executive summary:
The substance has been tested for acute toxicity after oral exposure, the test item was administered by gavage in a single dose of 5000 mg/kg bw to rats (5 male and 5 female).
After the administration, the animals were observed for 14 days. No deaths occurred and no clinical symptoms were recorded.
The acute oral median lethal dose LD50 of test item in rats is greater than 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 180-200 g
- Housing: They were caged in groups of five by sex in solid floor polypropylene cages furnished with sterilised sawdust. Sawdust was replaced twice per week
- Diet : free access to mains water and food (Rat ar..d Mouse No. 1 Expanded Diet, BP Nutrition (UK) Ltd., Stepfield, Witham, Essex)
- Acclimation period: 3 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): The ventilation system gave 8-10 air changes per hour
- Photoperiod (hrs dark / hrs light): controlled lighting conditions - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A Timbrell dust generator was used to produce the atmosphere.
- Source and rate of air: 10 l/min
ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 0.86 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by gravimetric analysis
- Duration of exposure:
- ca. 4 h
- Concentrations:
- Calculated from compound usage (after exposure): 29.8 mg/l
Calculated from gravimetric analysis: 2.8 mg/l - No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for toxic or pharmacological effects during exposure and subsequently at least twice daily through a 14 days observation period.
- Frequency of weighing: immediately after expasure and an days 1, 3, 7, 10 and 14 after the day of exposure.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- ca. 2.8 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.8 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No deaths occurred during exposure or during the observation period as a result of exposure to the test material. One male treated rat suffocated as a result of turning around in the restraining tube.
- Clinical signs:
- other: For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal excretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted t
- Body weight:
- The mean body weights of the male and female control rats throughout the experiment, increase slowly during the first 4 days but thereafter more rapidly.
- Gross pathology:
- Those dying an the day of exposure also showed staining of the upper respiratory tract, however in the remainder of the rats which survived the observation period, there was a more generalised pulmonary staining.Staining of the renal cortex occurred in four male rats, and staining of the general musculature and testes in one male.
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- LC50 > 2.8 mg/l
- Executive summary:
The study was conducted according to a method similar to OECD Guideline 403. A single maximum concentration of test material (2.8 mg/l calculated from gravimetric analysis; 29.8 mg/l calculated from compound usage) was administered to 20 rats (10 male, 10 female) as a dust by inhalation (nose only) over a period of 4 hours. A further 10 rats (5 male, 5 female) were exposed under similar conditions to an atmosphere of filtered air. The concentration of test material, as measured by gravimetric analysis was 2.8 mg/l. No deaths occurred during exposure or during the observation period as a result of exposure to the test material. For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal execretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted throughout the observation period.
The substance shows a LC50 more than 2.8 mg/l.
Reference
All the treated rats had blue stained pelts.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 2.8 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral administration:
Three studies are available on acute oral toxicity conducted on the target substance.
The Key study (Huntsman, 1975) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period.
LD50 > 5000 mg/kg bw
As supporting studies the two other studies available on the target substance were reported:
The first study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage in distilled water at the concentration of 2000 mg/kg bw. No deaths occurred during the observation period.
LD50 > 2000 mg/kg bw
The second study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. . The test item was administered to rats in a single dose by gavage in CMC (carboxymethyl cellulose) at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period, nevertheless blue urine and foeces were observed.
LD50 > 5000 mg/kg bw
The three study of acute oral administration are similar, the main reason for selection is the highest purity of the Huntsman study conducted in 1975.
Acute inhalation administration:
One study is available by inhalation route. This study (BASF, 1978) was performed according to a method similar to OECD Guideline 403. A single concentration (2.8 mg/l calculated from gravimetric analysis; 29.8 mg/l calculated from compound usage) was administered to rats as a dust by inhalation (nose only) over a period of 4 hours. No deaths occurred during exposure or during the observation period as a result of exposure to the test material.
For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal excretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted throughout the observation period.
LC50 > 2.8 mg/l
Acute intraperitoneal administration
One study is available by intraperitoneal route. This study (BASF, 1978) was performed according to the method described in “Hazieton Manual of Standard Operating Procedures”. As preliminary study the animals were treated with a single intraperitoneal dose of test article at a dose level of 2000 mg/kg. All animals died within 24 hours of treatment. Following the initial study other mice were treated with a single intraperitoneal dose of test article within the range 216 - 1470 mg/kg. Deaths occurred in all the concentration tested.
LD50 = 380 mg/kg bw
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or an inhalation exposure of 4 hours.
The LC50 value for the oral administration is higher then 2000 mg/kg bw (LD50 > 5000 mg/kg bw) that is the trigger value for the acute oral toxicity classification.
The tested concentration in the acute inhalation exposure study is not above the value for avoiding the classification according the CLP Regulation (EC n. 1272/2008) but the tested value is an LC0 and the corresponding LC50 is more than 2.8 mg/l, therefore no classification is warranted for acute inhalation exposure.
Otherwise, the intraperitoneal administration is not considered as a route relevant for the classification pourpose.
Based on the data above, the substance is not classified for acute oral and inhalation toxicity.
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