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Diss Factsheets
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EC number: 262-797-3 | CAS number: 61444-38-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Oral: LD50= > 2000 mg/kg bw, male/female rat, OECD 423, RCC Ltd Toxicology Division 2000
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP; minor deviations not considered to affect the integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The animals were not fasted overnight prior to dosing
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The animals were not fasted overnight prior to dosing
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected November 1998; signature: March 1999
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males 237 - 265.5g; females 186.2 - 195.5g
- Fasting period before study: fasted 1 hour before treatment.
- Housing: Groups of three per sex in Makrolon type-4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): certified pelleted diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23.5
- Humidity (%): 40 - 61
- Air changes (per hr): 10 - 15
- Photoperiod: 12 hours light/12 hours dark
IN-LIFE DATES: 15/08/2000 To: 15/09/2000 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): 40537 4/1 30600
- Purity: not reported
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were examined for clinical signs fourvtimes during test day 1 and once daily during test days 2-15. Mortality/viability was recordedvtogether with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight. - Statistics:
- No statistical analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Slight rales were noted in all female animals on test day 2. Somnolence was observed in all male animals from 2 to 5 hours after the administration and slightly ruffled fur was observed in the same males from 1 to 5 hours (2 males) or from 2 to 5 hours (1
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in male and female Hanlbm: WIST (SPF) strain of rat was greater than 2000 mg/kg body weight.
- Executive summary:
The study was performed to EU Method B.1 and OECD 423 in accordance with GLP to assess the acute oral toxicity of the test material in the Hanlbm: WIST (SPF) strain of rat. The test material was administered orally, after fasting for 1 hour, once only by gavage. The test material concentration in the vehicle was 200 mg/ml and the administered volume of suspension was 10 ml/kg body weight. 3 male and 3 female test animals were dosed at 2000 mg/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 15 days. There were no deaths but slight rales were noted in all female animals on test day 2. Somnolence was observed in all male animals from 2 to 5 hours after the administration and slightly ruffled fur was observed in the same males from 1 to 5 hours (2 males) or from 2 to 5 hours (1 male). Hunched posture was observed additionally in one male animal (no.4) from 1 to 5 hours after the administration. Animals showed expected gains in bodyweight during the study. No test-related abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the male and female Hanlbm: WIST (SPF) strain rat was greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information as a whole meets the tonnage driven information requirements of REACH. The substance shows no evidence of acute toxicity by the oral route; no mortality below the limit dose and no significant macroscopic on gross necropsy.
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 study was performed to EU Method B.1 and OECD 423 in accordance with GLP to assess the acute oral toxicity of the test material in the Hanlbm: WIST (SPF) strain of rat. The test material was administered orally, after fasting for 1 hour, once only by gavage. The test material concentration in the vehicle was 200 mg/ml and the administered volume of suspension was 10 ml/kg body weight. 3 male and 3 female test animals were dosed at 2000 mg/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 15 days. There were no deaths but slight rales were noted in all female animals on test day 2. Somnolence was observed in all male animals from 2 to 5 hours after the administration and slightly ruffled fur was observed in the same males from 1 to 5 hours (2 males) or from 2 to 5 hours (1 male). Hunched posture was observed additionally in one male animal (no.4) from 1 to 5 hours after the administration. Animals showed expected gains in bodyweight during the study. No test-related abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the male and female Hanlbm: WIST (SPF) strain rat was greater than 2000 mg/kg bodyweight.
Justification for selection of acute toxicity – oral endpoint
Only one study available (Klimisch 1)
Justification for classification or non-classification
The substance does not meet classification criteria under EU Directive 67/548/EEC for acute toxicity.
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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