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EC number: 223-765-4 | CAS number: 4058-30-4
- 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
LD50 > 2000 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
- Study period:
- July 12, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: approximately 8 weeks.
- Weight at study initiation: males: 184 - 216 grams; females: 150 - 173 grams.
- Fasting period before study: overnight fasting.
- Housing: group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands).
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle Ag, Kaiseraugst, Switzerland) ad libitum.
- Water: ad libitum.
- Acclimation period: at least one week under laboratory conditions after physical examination. Only animals without any visual signs of illness were used for the study.
- Randomisation: randomly selected at time of delivery in groups of five.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was 12 hours artificial fluorescent light and 12 hours dark per day. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days.
- Mortality/Viability: at least three times each day.
- Body Weights: test days 1 (pre-administration), 8 and 15.
- Clinical Signs: each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations were performed four times during day 1, and once daily during days 2 - 15. All abnormalities were recorded.
- Necropsy: necropsies were performed by experienced prosectors. All animals were necropsied. All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period
- Clinical signs:
- other: no clinical signs of ill health or behavioural changes were observed during the study period
- Gross pathology:
- Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method:
The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401.
Observations:
No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy.
Results:
LD50 > 2000 mg/kg bw
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
The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401, at a limit dose of 2000 mg/kg bw. No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy. Therefore the LD50 calculated in this test was > 2000 mg/kg bw.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:
- Category 1: ATE ≤ 5 mg/kg bw
- Category 2: 5 < ATE ≤ 50 mg/kg bw
- Category 3: 50 < ATE ≤ 300 mg/kg bw
- Category 4: 300 < ATE ≤ 2000 mg/kg bw
The oral LD50 value was established to be more than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).
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