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EC number: 236-502-3 | CAS number: 13410-58-7
- 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
Oral (Gamer, 2005)
Under the conditions of the study, the median lethal dose of the test material after oral administration was found to be greater than 2,000 mg/kg bw in rats.
Inhalation (Waiver)
The study does not need to be conducted because exposure of human via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size – (exposure considerations).
Dermal (Waiver)
The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) – study scientifically not necessary / other information available).
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:
- 14 June 2004 to 07 October 2004
- 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
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrI:WIST(SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 -12 weeks
- Weight at study initiation: 177-179 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum .
- Housing: individually housed in stainless steel wire mesh cages, type DK-III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod: 12h/12h (6.00 a.m. - 6.00 p.m. / 6.00 p.m. - 6 .00 a.m.) - Route of administration:
- oral: gavage
- Vehicle:
- other: Olive oil Ph .Eur./DAB
- Details on oral exposure:
- VEHICLE
- Olive oil Ph .Eur./DAB
- Justification for choice of vehicle: Inhomogeneous in aqueous preparations. Olive oil Ph .Eur./DAB had to be used to ensure homogeneity of the preparation.
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION: The test material preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer. This formed a solution.
CLASS METHOD
- 2000 mg/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Recording of signs and symptoms several times on the day of administration and at least daily thereafter for 14 days.
- Individual body weights were determined shortly before administration (day 0), weekly thereafter and at the end of the study.
- A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy with gross-pathology examination was performed on the last day of the observation period after killing with CO2. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Clinical observation in the 2,000 mg/kg administration groups revealed impaired general state, dyspnoea, staggering and piloerection and were observed from hour 1 until including hour 4 after administration.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study.
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- Under the conditions of this study, the median lethal dose of the test material after oral administration was found to be greater than 2,000 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris and EPA OPPTS 870.1100, under GLP conditions.
During the study, single doses of 2,000 mg/kg body weight of test material preparations in olive oil Ph .Eur./DAB were given to two administration groups of three fasted female animals each, by gavage in a sequential manner.
No mortality occurred. Clinical observation revealed impaired general state, dyspnoea, staggering and piloerection. Findings were observed 1 to 4 hours after administration. The mean body weights of the administration groups increased throughout the study period and no macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.
Under the conditions of this study, the median lethal dose of the test material after oral administration was found to be greater than 2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
Oral (Gamer, 2005)
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris and EPA OPPTS 870.1100, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
During the study, single doses of 2,000 mg/kg body weight of test material preparations in olive oil Ph .Eur./DAB were given to two administration groups of three fasted female animals each, by gavage in a sequential manner.
No mortality occurred. Clinical observation revealed impaired general state, dyspnoea, staggering and piloerection. Findings were observed 1 to 4 hours after administration. The mean body weights of the administration groups increased throughout the study period and no macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.
Under the conditions of this study, the median lethal dose of the test material after oral administration was found to be greater than 2,000 mg/kg bw in rats.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the material does not require classification with respect to acute toxicity.
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