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EC number: 695-716-9 | CAS number: 1174931-74-8
- 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 and <= 5000 mg/kg bw, female rat; OECD 423, Lütkenhaus 2012
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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to guideline; under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.1000 (Acute Toxicity testing background)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 154 - 179g
- Fasting period before study: Prior to test material administration, food was withheld from test animals for 16-19 hours.
- Housing: Housed in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811).
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0815) ad libitum.
- Water (e.g. ad libitum): Tap water (sulphur acidified to a pH value of approximately 2.8) ad libitum.
- Acclimation period: At least 5 days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod: 12 hours light (artificial light)/12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/ml and 2000 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): MKBJ0602V
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limited information on test material, for animal welfare reasons the OECD 423 guideline recommends using a starting dose of 300 mg/kg body weight. - Doses:
- 300 mg/kg, 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Test animals were observed several times on the day of dosing with special attention during the first 4 hours. Thereafter test animals were observed for clinical signs once daily until the end of the observation period. Body weights were recorded on day 1 (prior to test material administration) and on days 8 and 15.
- Necropsy of survivors performed: yes - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - <= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed in any dose group.
- Clinical signs:
- other: 300 mg/kg dose group: no signs of toxicity. 2000 mg/kg dose group: slightly reduced spontaneous activity, bradykinesia, half eyelid-closure, slight piloerection.
- Gross pathology:
- Necropsy of the test animals showed no treatment-related macroscopic findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be between 2000 and 5000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain of rat. The study was performed to GLP and the method was designed to meet the requirements of OECD 423 guideline, EU method B.1 tris, OPPTS 870.1000 and 870.1100 guidelines. A stepwise approach was used to evaluate the toxicity of the test material. Absence or presence of compound-related mortality of the animals dosed at one step determined the next step. Groups of 3 animals were used for each dose. The test material was administered orally, after overnight fasting, once only by gavage, as a suspension in cotton seed oil. The test material concentrations in the vehicle were 300 mg/mL and 2000 mg/mL and the administered volume of suspension was 10 mL/kg body weight.Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. No clinical signs of toxicity were observed in the 300 mg/kg dose group. Clinical observations in the 2000 mg/kg bw group included: slightly reduced spontaneous activity, bradykinesia, half eyelid-closure, slight piloerection. Animals of the 300 mg/kg bw survived to the end of the study; animals in the 2000 mg/kg recovered within one day and also survived to the end of the study. All surviving animals showed expected gains in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be between 2000 and 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has a Klimisch score 1.
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 oral:
The acute oral toxicity of the substance was evaluated in the Wistar rat in a GLP study designed to meet the requirements of OECD 423. A stepwise approach was used to evaluate the toxicity of the test material. Absence or presence of compound-related mortality of the animals dosed at one step determined the next step. Groups of 3 animals were used for each dose. The test material was administered orally, after overnight fasting, once only by gavage, as a suspension in cotton seed oil. The test material concentrations in the vehicle were 300 mg/mL and 2000 mg/mL and the administered volume of suspension was 10 mL/kg body weight.Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. No clinical signs of toxicity were observed in the 300 mg/kg dose group. Clinical observations in the 2000 mg/kg bw group included: slightly reduced spontaneous activity, bradykinesia, half eyelid-closure, slight piloerection. Animals of the 300 mg/kg bw survived to the end of the study; animals in the 2000 mg/kg recovered within one day and also survived to the end of the study. All surviving animals showed expected gains in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be between 2000 and 5000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only one study available; study estimates the LD50 range and therefore provides information on a discriminating dose level (the highest concentration administered that has not caused significant effects to the test organisms).
Justification for classification or non-classification
The test substance does not meet classification criteria under EU Directive 67/548/EEC for acute toxicity.
The test substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.
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