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EC number: 228-779-4 | CAS number: 6358-57-2
- 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:
- From December 10th to 26th, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop ZRT
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old in first and second step
- Weight at study initiation: 150 - 152 g (at first step); 153 - 159 g (at second step)
- Housing: 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Fasting before treatment: yes, overnight
- Acclimation period: 5 days (first step); 6 days (second step)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 per hr
- Photoperiod: 12 h daily form 6 a.m. to 6 p.m. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: starting dose was selected on the basis of the available information about the test item.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (first setp)
3 (second step) - Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter.
- General state, external appearance, behavior and clinical symptoms: individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Body weight: the body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
- Necropsy: at the end of the observation period all rats were sacrificed under isofluran anaesthesia. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No death occurred at 2000 mg/kg bw single oral dose of test substance. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- In group 1 treated with 2000 mg/kg bw dose clinical sign of reaction comprised of red faeces (6 cases of 57 observations) and diarrhoea (3/57). Red faeces (score +4, +3) was observed in all animals between 4 hours after the treatment and day 1. Diarrhoea (score +2, +3) was found in all animals on the treatment day 4 hours after the treatment.
In group 2 treated with 2000 mg/kg bw dose clinical sign of reaction comprised of red faeces (6 cases of 57 observations) and diarrhoea (3/57). Red faeces (score +4, +3) was observed in all animals between 4 hours after the treatment and day 1. Diarrhoea (score +2) was found in all animals on the treatment day 4 hours after the treatment. - Body weight:
- The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.
- Gross pathology:
- All animals treated with 2000 mg/kg bw dose survived until the scheduled necropsy on day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose. - Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 2000 mg/kg bw.
- Executive summary:
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in 3 female rats.
No death occurred after the single 2000 mg/kg bw oral dose of test substance. As no deaths occurred in the first step, treatment was repeated on 3 further female rats. No animal died in the second step too, so the test was finished.
The observed clinical sign as diarrhoea were related to the effect of the test item. The alteration as red colored faeces was connected with the physical property of test item.
There were not any changes related to the systemic toxic effect of the test item found in body weights and body weight gains during the study.
Autopsy revealed no treatment related pathological changes.
Accordingly, LD50 is > 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 acute toxic class method was run according to OECD guideline 423 using a stepwise procedure. The starting dose in 3 female rats was 2000 mg/kg bw; no deaths occurred in the first step, thus 3 further female rats were dosed at the same level. No deaths occurred in the second step too. Observations were carried out for 14 days after dosing.
Clinical signs, noted in both steps, were diarrhoea and red feces (due to the physical properties of test item).
No effects on body weight and no gross pathological changes were noted.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), classification for acute oral toxicity is based on the LD50 value.
The threshold value for classification is 2000 mg/kg bw. As no deaths were seen at this dose level, no classification applies within the CLP Regulation (EC 1272/2008).
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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