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EC number: 274-999-9 | CAS number: 70900-27-5
- 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 >2000 mg/kg bodyweight in female rats
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:
- 08 September 2015 to 23 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- - see below
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- - see below
- Principles of method if other than guideline:
- The temperature was out of the target range during the acclimation period, (maximum of 26.3 °C). The relative humidity was out of the target range during the experiment, (minimum of 24 %).
These deviations have no presumed effect on the outcome or validity of the study. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CRL:(WI) (SPF)
- Age at study initiation: 9 weeks old
- Weight at study initiation: 183 to 213 g
- Fasting period before study: Overnight food withdrawal prior to dosing. Food was made available again 3 hours after the treatment.
- Housing: 3 animals per cage in Type II polypropylene/polycarbonate cages with wooden chips available as bedding
- Diet: ad libitum
- Water: ad libitum access to tap water from the municipal supply in a 500 mL bottle
- Acclimation period: 12, 13 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20.0 to 26.3 °C
- Relative Humidity: 24 to 68 %
- Air changes: 15 to 20 air exchanges/hour
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES
From: 27 August 2015
To: 22 and 23 September 2015 - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: The test material was freshly formulated on the day of administration. The formulation container was stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females per dose
Two groups of 3 female rats were treated with the test material at 2000 mg/kg, Group 1 and Group 2 - Control animals:
- no
- Details on study design:
- - Dosing: Initially, 3 female animals were treated with 2000 mg/kg bw of test material. No mortality was observed, therefore further 3 animals were treated at the dose level of 2000 mg/kg bw. As no mortality was observed in this second dose group, further testing was not required.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: Yes, macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal® 40 % injection). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed and macroscopic abnormalities were recorded. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Acute oral administration of test material caused symptoms of liquid faeces and coloured faeces in all animals; the symptoms appeared after 3 hours of dosing in 4 animals and 4 hours after dosing in 2 animals. From Day 2 all animals became symptom-free.
- Gross pathology:
- No abnormalities were noted at necropsy; there were no macroscopic observations.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the LD50 was determined to be >2000 mg/kg bw in female rats.
- Executive summary:
The acute oral toxicity of the test material was assessed in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris under GLP conditions.
Two groups of 3 female CRL:(WI) rats were treated with the test material in distilled water at a dose level of 2000 mg/kg bw (Group 1 and Group 2). A single oral treatment was carried out by gavage for each animal at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required.
Clinical observations were performed, body weight was measured and all animals were subjected to a necropsy and a macroscopic examination. At study termination animals were subjected to a macroscopic examination.
No mortalities were observed. Liquid faeces and coloured faeces were observed in all animals on the day of dosing. The test material had no effect on body weight and no abnormalities were noted at necropsy.
Under the conditions of this study, the LD50 was determined to be >2000 mg/kg bw in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The key study was conducted under GLP conditions in accordance with standardised guidelines and was assigned a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be high.
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
Acute Toxicity: Oral
The acute oral toxicity of the test material was assessed in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris under GLP conditions.
Two groups of 3 female CRL:(WI) rats were treated with the test material in distilled water at a dose level of 2000 mg/kg bw (Group 1 and Group 2). A single oral treatment was carried out by gavage for each animal at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required.
Clinical observations were performed, body weight was measured and all animals were subjected to a necropsy and a macroscopic examination. At study termination animals were subjected to a macroscopic examination.
No mortalities were observed. Liquid faeces and coloured faeces were observed in all animals on the day of dosing. The test material had no effect on body weight and no abnormalities were noted at necropsy.
Under the conditions of this study, the LD50 was determined to be >2000 mg/kg bw in female rats.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral route.
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