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EC number: 600-891-1 | CAS number: 1089-78-7
- 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
LD50 oral > 2000 mg/kg bw. [Kurth 2007]
LD50dermal > 2000 mg/kg bw. [Kurth 2007]
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:
- November 2005 to January 2006
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (101 - 117 g); females (102 - 110 g)
- Fasting period before study: approximately 18-19 hours
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 55 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: 9.0 mg NaCl + 0.85 mg Myrj 53 ad 1 mL water for injection (Ampuwa)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: I: N1630A01, II: N1637A01
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations and weighing: at least once daily (clinical observation), once weekly (body weight)
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: No compound-related findings occurred.
- Gross pathology:
- No treatment-related findings were observed.
- Executive summary:
The acute oral toxicity of the test substance was low with a LD50 (cut-off value) > 2000 mg/kg bw in rats according to OECD TG 423. A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No effect on body weight gain occured in male rats. Administration was tolerated without mortalities, clinical findings and gross pathological findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This study is GLP compliant and is of high quality (Klimisch Score = 1).
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 2006 - Mar 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (238 - 250 g); females (201 - 208 g)
- Fasting period before study: no data
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 54 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4 x 9 cm
- % coverage: approximately 10% of the body surface area of a rat
- Type of wrap: gauze
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 477-499 mg (male animals), 402-421 mg (female animals)
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.7 mL
- Concentration: 0.9%
- Lot/batch no.: 4342A191
- Purity: no data - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weighing)
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: One female animal showed a punctiform scab formation on the abdomen on day 3 and 4 of the study. It is considered to be a spontaneous finding. No compound-related findings were observed in male and female animals.
- Gross pathology:
- No compound-related effects were noted.
- Executive summary:
A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings and gross pathological findings. After administration of the test substance a slight decrease in body weight was observed in all male animals and one female animal on day 7 of the study. This effect was reversible on day 14. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This study is GLP compliant and is of high quality (Klimisch Score = 1).
Additional information
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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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