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EC number: 203-942-2 | CAS number: 112-17-4
- 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
The substance is not acute toxic. The oral LD50 is > 4315 mg/kg bw.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Principles of method if other than guideline:
- The test is performed for suspected low toxic materials to determine an approximate order of toxicity. 3 male and 3 female animals are dosed with the most relevant dose levels for the class of substance. Two groups of 1 male and 1 female are dosed above and below this level.
The animals are observed for 7 days. - GLP compliance:
- not specified
- Test type:
- other: Range finding study
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks old
- Fasting period before study: yes, 4h
- Diet: commercial pelleted diet
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 8630, 4315 and 1726 mg/kg bw (corresponding to 10.0, 5.0 and 2.0 mL/kg bw).
- No. of animals per sex per dose:
- 1 male and 1 female for highest and lowest dose, 3 males and 3 females for middle dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: at the beginning of the test and before killing
- Necropsy of survivors performed: yes - Statistics:
- The LD50 value is estimated from the results and the test substance is given a toxicity rating according to Hodge and Sterner's classification.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 315 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the test.
- Clinical signs:
- No clinical signs were observed at any dose level. The animals presented a normal appearance at autopsy.
- Body weight:
- Weight gain was normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not acute toxic, the LD50 is > 4315 mg/kg bw.
- Executive summary:
The test is performed for suspected low toxic materials to determine an approximate order of toxicity using 5 male and 5 female animals. The most relevant dose levels for the class of substance is selected, and 3 male and 3 female animals are dosed at this level. Two groups of 1 male and 1 female are dosed above and below this level.
The study was similar to OECD TG 423, however, with deviations such as the observation period after dosing of 7 days.
The animals were dosed 8630, 4315 or 1726 mg/kg bw and observed for 7 days. Body weight was assessed at the beginning of the test and before killing of the animals. All animals were necropsied.
No animals died during the test and no clinical signs were observed at any dose level. Weight gain was normal and the animals presented a normal appearance at autopsy.
In the study the LD50 was therefore > 8630 mg/kg, however, according to the OECD TG 423 the substance is tested using a stepwise procedure, each step using 3 animals of a single sex (normally females). For the middle dose the accurate amount of animals was used in this study and therefore the LD50 is > 4315 mg/kg bw. The substance should not be considered as acute oral toxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 315 mg/kg bw
- Quality of whole database:
- The study was similar to internationally accepted guidelines and well documented. An LD50 was determined.
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
For the acute toxicity endpoint there is one study available.
In the key study (1980) the oral acute toxicity was assessed in 5 male and 5 female mice. The study was similar to OECD TG 423, with a deviation for the observation period after dosing and the amount of animals used per dose. 2 animals were dosed 8630 or 1726 mg/kg bw and 6 animals were dosed 4315 mg/kg bw. The observation period was 7 days. No animals died during the test and no clinical signs were observed at any dose level. Weight gain was normal as well as the autopsy. For the middle dose sufficient animals were used and therefore the LD50 is > 4315 mg/kg bw.
Concluding, the test item is not acute toxic for the oral route.
Justification for classification or non-classification
According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the oral route is =< 2000 mg/kg bodyweight. The oral LD50 of the test item is 4315 mg/kg bw and thus the substance is not to be classified as acute toxic for the oral route.
The available data is sufficient to not classify the substance as an acute toxic substance.
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