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EC number: 272-897-9 | CAS number: 68919-40-4
- 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
Based on a LD50 oral in mice of 9800 mg/kg bw, the registered substance is not classified for acute oral toxicity according to CLP and GHS UN criteria.
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:
- no specified (1978)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Observation period of 5 days instead of 14 days. Body weight measurement and necropsy not reported.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: not specified
- Weight at study initiation: 18 to 21g
- Fasting period before study: not specified
- Housing: in wire cages, 5 animals/cage
- Diet (e.g. ad libitum): Lab blox ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: not specified - Route of administration:
- oral: gavage
- Vehicle:
- water
- 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): not specified
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: not specified - Doses:
- 8330, 10000, 11600 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: not specified - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 9 800 mg/kg bw
- Based on:
- not specified
- Mortality:
- Dose group 8330 mg/kg bw: 2/10
Dose group 10000 mg/kg bw: 5/10
Dose group 11600 mg/kg bw: 8/10 - Clinical signs:
- other: no specified
- Gross pathology:
- not assessed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a LD50 in mice of 9800 mg/kg bw, the registered substance is not classified for acute oral toxicity according to CLP and GHS UN criteria.
- Executive summary:
The registered substance has been tested for acute oral toxicity in CF-1 mice (product name = Miranol C2M AA). The test article was administered after a 1:2 dilution in water in a single oral dose to three groups of 10 mice at a dose volume of 8.33, 10.0 and 11 g/kg, respectively. Examinations for mortality and clinical signs were performed daily during a 5-day observation period.
A mortality of 20% was observed in the group receiving the lowest dose, 50% in the group treated at 10 g/kg, and 80% in the group receiving 11 g/kg. The acute oral toxicity was calculated to be 9.8 g/kg (with 95% confidence limits of 8.9-10.8 g/kg) i.e. 9800 mg/kg bw.
As the acute oral LD50 is higher than 5000 mg/kg b.w., the registered substance is not classified according to CLP and GHS UN criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 9 800 mg/kg bw
- Quality of whole database:
- Studu of reliabilty 2 according to Klimish criteria
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
One study of Klimish score 2 is available to assess the acute oral toxicity (Levenstein, 1978). In this study,
the registered substance has been tested for acute oral toxicity in CF-1 mice (product name = Miranol C2M AA). The test article was administered after a 1:2 dilution in water in a single oral dose to three groups of 10 mice at a dose volume of 8.33, 10.0 and 11 g/kg, respectively. Examinations for mortality and clinical signs were performed daily during a 5-day observation period.
A mortality of 20% was observed in the group receiving the lowest dose, 50% in the group treated at 10 g/kg, and 80% in the group receiving 11 g/kg. The acute oral toxicity was calculated to be 9.8 g/kg (with 95% confidence limits of 8.9-10.8 g/kg) i.e. 9800 mg/kg bw.
As the acute oral LD50 is higher than 5000 mg/kg b.w., the registered substance is not classified according to CLP and GHS UN criteria.
Justification for classification or non-classification
According to the CLP and GHS UN criteria, the registered substance can be ranked as “Unclassified” for acute oral toxicity as a LD50 of 9800 mg/kg bw was determined in mice.
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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