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EC number: 947-851-2 | CAS number: -
- 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
A single dose of 2000 mg/kg/bw of the test item was administered to 6 female Sprague-Dawley rats. Acute toxicological symptoms such as abnormal gait, decreased locomotor activity/irregular respiration, decreased faecal volume and lying on one side/ soiled perineal region were all observed throughout the test. Body weight changes were observed in one rat. No grossly visible findings were observed in any animal during the test.
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:
- 30 January 2018 to 06 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague-Dawley rats bred by commercial supplier
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 7 weeks
- Weight at study initiation: 179.9 – 202.5 g
- Fasting period before study: Overnight before the day of administration.
- Housing: Housed individually in stainless wire mesh cages (Width: 260 mm, Diameter: 350 mm, Height: 210 mm)
- Diet (e.g. ad libitum): Pelleted rodent chow was placed in feeders and provided ad libitum
- Water (e.g. ad libitum): Filtered/irradiated public tap water was provided ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5−24.6°C
- Humidity (%): 41.7−59.3%
- Air changes (per hr): 10−15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage): Not specified
- Justification for choice of vehicle: Not specified
- Lot/batch no. (if required): MKCC0462
- Purity: Not specified
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg body weight
DOSAGE PREPARATION (if unusual): Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the low expected toxicity of the test substance, 2000 mg/kg was used as the starting dose. - Doses:
- Doses
- 2000 mg/kg of the test substance was intended to be orally administered as a single dose to each of the two groups of female rats indicated.
Number of animals per group per dose
- G1: 2101-2103: (2000 mg/kg) 3 females
- G2: 2201-2203: (2000 mg/kg) 3 females
Since there were no mortalities after the dosing of the first two groups, the study was stopped at that point. - No. of animals per sex per dose:
- Group 1 2101-2103: 3 females
Group 2: 2201- 2203: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Two observations were made on day 0; followed by daily observations
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight and gross pathology at necropsy - Statistics:
- Not performed
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut off based on GHS classification is >=5000
- Mortality:
- There were no deaths of animals observed at the dose of 2000 mg/kg throughout the study.
- Clinical signs:
- other: Acute toxicological effects such as abnormal gait, decreased locomotor activity, irregular respiration, decreased faecal volume and lying on side or soiled perineal region were observed.
- Gross pathology:
- None changes in the tissues were observed
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- In conclusion, the oral LD50 value is greater than 2000 mg/kg bw. According to the LD50 cut off value of ≥ 5,000 mg/kg b.w., the test substance is classified as Category 5 according to the GHS classification and unclassified according to the EU CLP criteria (EC 1272/2008).
- Executive summary:
The acute oral toxicity study (2018) is a GLP-compliant study following OECD guideline 423 and is therefore reliable without restrictions (Klimisch 1).
A single dose of 2000 mg/kg/bw of the test item was administered to a total of 6 female Sprague-Dawley rats. Acute toxicological symptoms such as abnormal gait, decreased locomotor activity/irregular respiration, decreased faecal volume and lying on one side/ soiled perineal region were all observed throughout the test. Body weight changes were observed in one rat. No grossly visible findings were observed in any animal during the test.
There were no deaths observed throughout the study from the dose of 2000 mg/kg. Therefore, the LD50 was considered to be > 2000 mg/kg. Based on the LD50 cut off value of ≥ 5,000 mg/kg b.w the test substance is classified as Category 5 according to the GHS classification and unclassified according to the EU CLP criteria (EC 1272/2008).
Reference
Table 1- Mortality results
Group |
Dose (mg/kg) |
Dose volume (mL/kg) |
Animal (ID No.) |
Deaths |
1 |
2000 |
5 |
3 (2101-2103) |
None |
2 |
2000 |
5 |
3 (2201-2203) |
None |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The acute oral toxicity study (2018) is a GLP-compliant study following OECD guideline 423 and is therefore reliable without restrictions (Klimisch 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
Justification for classification or non-classification
An assessment of acute toxicity is required to fulfil REACH Annex VII information requirements. The acute oral toxicity study was conducted according to OECD TG 423. The GLP compliant study is considered reliable without restriction (Klimisch 1).
There were no deaths observed throughout the study from the dose of 2000 mg/kg. Therefore, the LD50 was considered to be > 2000 mg/kg. Based on the LD50 cut value of ≥ 5,000 mg/kg b.w the test substance is classified as Category 5 according to the GHS classification and unclassified according to the CLP regulation.
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