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EC number: 639-824-6 | CAS number: 1229457-94-6
- 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 acute oral study with Wistar rats (Beerens- Heijnen., 2010) is available which is key study. The oral LD50 value of the test substance was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight.
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:
- From 3 September to 12 October 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han) (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Approx. 8-10 weeks old
- Weight at study initiation: Bodyweight variation was within +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Housed in a controlled environment
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.6 - 21.6ºC)
- Humidity (%): A relative humidity of 40-70% (actual range: 42 - 75%)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: 3 September 2010 To: 12 October 2010 - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Aqueous carboxymethyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
- Lot/batch no. (if required):
- Purity: 1% w/v - Doses:
- Dose level (volume) 2000 mg/kg (10 mL/kg) body weight
300 mg/kg (10 mL/kg) body weight
50 mg/kg (10 mL/kg) body weight - No. of animals per sex per dose:
- 2000 mg/kg body weight 3 females
300 mg/kg body weight 3 females
50 mg/kg body weight 3 females
50 mg/kg body weight 3 females - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability Twice daily. Body weights Days 1 (pre-administration), 8 and 15. Clinical signs At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day15.
- Necropsy of survivors performed: yes. The animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 50 - 300 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: LD50 cut off was considered to be 200 mg/kg
- Mortality:
- No death at 50 mg/kg. For concentration 300 and 2000 mg/kg, all animals died two hours after dosing.
- Clinical signs:
- other: No clinical signs were noted in the animals at 2000 and 300 mg/kg, which all died two hours after dosing.. All animals at 50 mg/kg showed hunched posture on Day 1 and/or 2. In addition three animals showed piloerection and lethargy on Day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of the test substance in Wistar rats was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
- Quality of whole database:
- 1 (reliable without restriction)
Additional information
A acute oral study with Wistar rats (Beerens- Heijnen., 2010) was conducted accroding to OECD 423. The oral LD50 value of the test substance was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
Study run to a method comparable with current guidelines and to GLP
Justification for classification or non-classification
Based on the avaliable data, the substance was classfied as Toxicity Category III accroding to Regulation (EC) No. 1272/2008 Table 3.1.1.
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