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EC number: 217-992-8 | CAS number: 2033-24-1
- 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
Acute oral toxicity:
The acute oral LD50 on Albino rats was determined to be > 5000 mg/kg for males and females.
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:
- March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: the study was performed before GLP- and OECD-testing guidelines were available and in force; therefore the study was considered to have Klimisch 2, however it provides enough information to assess the acute toxicity to rats after oral application
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd., Grimston, Aldbrough, Nr. Hull, UK
- Age at study initiation: no data
- Weight at study initiation: 125 - 225 g
- Diet (e.g. ad libitum): Food (Rat and Mouse No. 1 Expanded Diet SQC, BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex).
- Water (e.g. ad libitum): Mains water was provided and dipensed from glass water bottles
- Acclimation period: 6 days
- Fasting period: overnight fast (for 18 - 20 hours before treatment)
- Housing: Caged in groups of 2 or 5 as appropriate in solid-bottomed plastic cages furnished with softwood sawdust which was replaced twice each week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Air changes (per hr): air-conditioned room
- Photoperiod (hrs dark / hrs light): fluorescent lighting during working hours (08.45 - 17.00) - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE:
- Concentration in vehicle:
Group 1 - 250 mg/kg: 25 mg/ml
Group 2 - 500 mg/kg: 50 mg/ml
Group 3 - 1000 mg/kg: 100 mg/ml
Group 4 - 2000 mg/kg: 200 mg/ml
Group 5 - 5000 mg/kg: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
DOSAGE PREPARATION:
Suspensions of the test article were prepared in 1% methyl cellulose - Doses:
- Dose levels of 250, 500, 1000, 2000 (DRF) and 5000 mg/kg (main study) were tested.
- No. of animals per sex per dose:
- Four groups each of 4 fasted rats (2 males, 2 females) and 1 group of 10 fasted rats (5 males, 5 females) were dosed according to the following scheme:
RANGE-FINDING:
Group 1 - 250 mg/kg: 2 males / 2 females
Group 2 - 500 mg/kg: 2 males / 2 females
Group 3 - 1000 mg/kg: 2 males / 2 females
Group 4 - 2000 mg/kg: 2 males / 2 females
MAIN STUDY:
Group 5 - 5000 mg/kg: 5 males / 5 females - Control animals:
- no
- Details on study design:
- OBSERVATION:
Duration of observation period following administration: 14 days
FREQUENCY OF OBSERVATIONS AND WEIGHING:
Dose range-finding study: mortalities recorded during the 48 hours following treatment.
Main group: appearance, behaviour and general observations were observed for overt signs of toxicity or behavioural change at 1/4, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days.
BODY WEIGHTS:
Body weight: Individual body weights were recorded on the day before treatment, on the day of treatment and 7 and 14 days after treatment.
NECROPSY:
Any animal that died during working hours or was killed in extremis or appeared sick at the end of the observation period was subjected to a gross necropsy examination. Animals surviving at the end of the study were killed by exposure to high levels of carbon dioxide. - Preliminary study:
- A dose-range finding study was conducted with dose levels of 250, 500, 1000 and 2000 mg/kg
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose range-finding study (250-2000 mg/kg):
No deaths were noted at the end of the 48 hour observation period
Main study (5000 mg/kg):
No deaths were noted at the end of the 48 hour observation period - Clinical signs:
- other: All animals appeared normal during the observation period
- 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 on Albino rats was determined to be > 5000 mg/kg for males and females.
- Executive summary:
A study was carried out equivalent or similar 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 from 250 up to 5000 mg/kg. Neither mortality nor clinical signs were noted in any of the dose groups. Animals showed normal body weight gains at the end of the 14 d observation period. Necropsy was not performed. The LD50 was determined to be > 5000 mg/kg for both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Klimisch 2 study; test design equivalent or similar to OECD 401
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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