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EC number: 245-043-8 | CAS number: 22502-03-0
- 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
Endpoint summary
Administrative data
Description of key information
A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses of 50, 250, 1250 and 5000 mg/kg in the pretest and with 5000 mg/kg in the main study. The LD50 was determined to be ca. 5000 mg/kg for both sexes.
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:
- November-December 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study (non-GLP)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldbrough, Nr. Hull
- Weight at study initiation: 125-146 g
- Housing: five animals per cage by sex and dose group
- Diet (e.g. ad libitum): Rat and Mouse Food No. 1 Modified, BP Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): recorded daily
- Photoperiod (hrs dark / hrs light): 12 hours artificial light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test article preparations were administered once only by oral gavage using a metal stomach tube (14 gauge x 8 cm,
Stand Medicals Ltd., Manchester) attached to a 2 ml disposable plastic syringe. Individual doses were based on the fasted body weight of the animals at the time of treatment. - Doses:
- PRELIMINARY STUDY:
- 50, 250, 1250 and 5000 mg/kg
MAIN STUDY:
- 5000 mg/kg - No. of animals per sex per dose:
- PRELIMINARY STUDY:
- 2 males & 2 females
MAIN STUDY:
- 5 males & 5 females - Control animals:
- no
- Preliminary study:
- No deaths were noted at the end of the 48-hour observation period.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four animals (1 male, 3 females) died during the study. The females died 24-48 hours after treatment and the male on day 4.
- Clinical signs:
- other: All treated animals were lethargic 15 minutes after dosing. The majority continued to be lethargic throughout the day of dosing. Other toxic signs noted 2-4 hours after treatment were hunched posture and piloerection. Signs of intoxication noted in surviv
- Gross pathology:
- No necropsies were performed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity LD50 on WistarAlbino rats was determined to be ca. 5000 mg/kg for males and females.
- Executive summary:
A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses of 50, 250, 1250 and 5000 mg/kg in the pretest and with 5000 mg/kg in the main study. No mortality was observed in the pretest. Four animals (1 male, 3 females) died during the main study. All treated animals were lethargic 15 minutes after dosing. The majority continued to be lethargic throughout the day of dosing. Other toxic signs noted were hunched posture, piloerection, prostration, emaciation, perinasal haemorrhage, deep, rapid breathing, and difficult or laboured breathing. All surviving animals appeared normal 7 days after treatment. Animals showed normal body weight gains at the end of the 14 day observation period. Necropsy was not performed. The LD50 was determined to be ca. 5000 mg/kg for both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Klimisch 2 study; test design according to OECD 401 (non-GLP)
Justification for classification or non-classification
Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).
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.
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