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EC number: 228-536-2 | CAS number: 6290-17-1
- 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
Acute oral toxicity (OECD423): 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:
- 19 March 2002 - 5 April 2002
- 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:
- 22 March 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- January 1997
- 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: stock SHOE:WIST, Tierzucht Schonwalde GmbH
- Females nulliparous and non-pregnant: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: 145-151 g
- Fasting period before study: aprox. 18 hours prior to dosing
- Housing: transparent polycarbonate cages, with two or three in each cage, males and females separated.
- Diet: pelleted complete rodent diet "Altromin 1314" from Altromin GmbH, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20-March-2002 To: 4-April-2002 (males) and From: 22-March-2002 To: 6-April-2002 (females) - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: according to guidelines.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the starting dose was chosen in accordance with OECD guideline 423. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 males and 3 females, both receiving the highest dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1, 3 and 6 hours after the administration and thereafter daily
- Frequency of weighing: on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and pathological findings - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: - Males: Animals No. 1, No. 2 and No. 3 showed decreased motor activity, a pinched abdomen and piloerection 1 and 3 hours after the application of the test article. After 6 hours a pinched abdomen and piloerection were observed in the three animals, where
- Gross pathology:
- No pathological abnormalities were found after gross necropsy.
- Interpretation of results:
- other: Not acute harmful.
- Remarks:
- In accordance with EU CLP (EC. No. 1272/2008 and its amendments).
- Conclusions:
- Under the experimental conditions described in this report, the oral LD50 of the substance in rats was found to be above 2000 mg/kg bw. Therefore, the substance is considered to be not acute harmful.
- Executive summary:
In this study performed according to OECD TG 423 guideline and GLP principles, 6 rats (3 males and 3 females) were administered with the substance at a dose level of 2000 mg/kg bw. Observations were made for 14 days after dosing. No mortality occurred. Pinched abdomen and piloerection was observed in all animals until 6 hours after dosing. From day 1 until the end of the study, no abnormal clinical signs were observed. Rats showed a normal weight gain during the study period. No pathological abnormalities were found after gross necropsy. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral toxicity:
In a study performed according to OECD TG 423 guideline and GLP principles, 6 rats (3 males and 3 females) were administered with the substance at a dose level of 2000 mg/kg bw. Observations were made for 14 days after dosing. No mortality occurred. Pinched abdomen and piloerection was observed in all animals until 6 hours after dosing. From day 1 until the end of the study, no abnormal clinical signs were observed. Rats showed a normal weight gain during the study period. No pathological abnormalities were found after gross necropsy. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance is not classified for acute toxicity by the oral route.
Justification for classification or non-classification
Based on the results of an acute oral toxicity study (LD50 > 2000 mg/kg bw), the substance is not classified as acute harmful according to EU CLP (EC No. 1272/2008 and its amendments).
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