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EC number: 611-799-6 | CAS number: 59121-99-2
- 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
The acute oral toxicity in rats of the test item was determined in an OECD guideline study (BASF, 1999). The LD50 was determined to be > 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:
- 1999-06-22 to 1999-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight; (150g - 300g) (+/- 20% of the mean weight)
- Fasting period before study: The animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in steinless steel wire mesh cages, type DK-III, Becker & Co., Castrop-Rauxel, FRG
- Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: Fully air conditioned rooms
- Photoperiod: 12 / 12 (h dark / h light) (6.00 a.m.- 6.00 p.m. / 6.00 p.m. - 6.00 a. m.) - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40.000 g/100 mL
- Justification for choice of vehicle: Good solubility in olive oil
MAXIMUM DOSE VOLUME APPLIED: 5.00 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw has been chosen in a first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw have been tested in a second step with animals of the other sex (3 male rats). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 x female
3 x male - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Weighing shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.
- Necropsy of survivors performed: Yes. Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with C02; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.
- Other examinations performed: clinical signs, body weight, grosspathology examination - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality occured in both test groups.
- Clinical signs:
- Number of male animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Abdominal position: 3
Staggering: 3
Piloerection: 3
Smeared fur: 1
Number of female animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Staggering: 3
Diarrhea: 1 - Body weight:
- The expected body weight gain was observed in the course of the study.
- Gross pathology:
- No abnormalities were noted.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP guideline study
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:
The study was performed to assess the acute toxicity following oral administration of the test item, applied as a solution in olive oil, in Wistar rats. The study procedure was based on the EC and OEÇD guidelines. To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg body weight was given. Signs of toxicity noted in the male and female animals comprised impaired and poor general state, dyspnoea, apathy and staggering. The male animals additionally showed abdominal position and a female rat also exhibited diarrhea. The animals appeared normal within 2 days after application. The expected body weight gain was observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test item after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.
Justification for selection of acute toxicity – oral endpoint
GLP and guideline study
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221.
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