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EC number: 290-923-7 | CAS number: 90294-39-6
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 19 to May 3, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- In two males the allowed initial body weight was exceeded by 2 and 3 g, respectively.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif : RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 182 to 243 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: at least for 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Volume applied: 10 ml/kg body weight - Doses:
- 2000 mg/kg (males and females)
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: - Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days: - Signs and symptoms: daily for 14 days; - Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes, The animals were submitted to a gross necropsy at the end of the observation period. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study
- Clinical signs:
- other: Pilerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days.
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method:
The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401 and EU Method B.l.
Observations:
Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days. At necropsy, no deviations from normal morphology were found in all animals.
Results:
LD50 > 2000 mg/kg bw
Reference
Necropsies
At necropsy, no deviations from normal morphology were found in all animals.
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
No studies on the "Acute Oral Toxicity" are available for the substance in itself.
Nevertheless studies were conducted with an analogue molecule (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.
Different available tests may be considered, that gives information on Acute Oral Toxicity.
The key study was performed according to OECD guideline 401, following administration of a single limit dose (2000 mg/kg bw). No mortality occurred during the study . Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 days. At necropsy, no deviations from normal morphology were found in all animals. The acute oral LD50 was determined to be > 2000 mg/kg bw.
The supporting study was performed according to OECD guideline 401. The rats were treated with the substance at multiples doses (1000, 2500, 5000 mg/kg bw) by oral administration. At a concentrations of 2500 mg/Kg a death occured after a day. At 5000 mg/Kg bw eight animals died after a day. The acute oral LD50 was determined to be 3644 mg/kg bw.
The results obtained with a further test, conducted according to a method similar to OECD guideline 401, showed a LD50 > 5000 mg/kg bw, which is in line with the results obtained in the tests described above.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).
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