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EC number: 221-698-5 | CAS number: 3195-78-6
- 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
In an acute oral toxicity study in rats a LD50 value of 1760 mg/kg bw was obtained. No mortality occurred in an acute inhalation toxicity study when rats were exposed with the test item in concentrations of 4000 ppm (16207 mg/m³). The LD50 value determined was 1.41 mL/kg bw (corresponding to 1354 mg/kg bw) in an acute dermal toxicity study in rabbits.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats (10/dose) were fasted before dosing for 12 hours.
Animals were treated in concentrations of 800-5000 mg/kg bw/day via gavage.
Observation period was at least 48 hours. - GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- other: please refer to principles of method if other than guideline
- Limit test:
- no
- Species:
- rat
- Strain:
- other: SPF Wistar K
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 80-106 g
- Fasting period before study: 12 hours before administration
- Diet: Standard-ALTROMIN R
- Water: tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 10% aqueous solution
- Doses:
- 800 mg/kg bw
1250 mg/kg bw
2000 mg/kg bw
3200 mg/kg bw
5000 mg/kg bw - No. of animals per sex per dose:
- 10 per dose (only females)
- Details on study design:
- - Duration of observation period following administration: 7 days
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 760 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Death occured within 100 min - 48 hours:
1250 mg/kg bw: 1/10
2000 mg/kg bw: 8/10
3200 mg/kg bw: 10/10
5000 mg/kg bw: 10/10 - Clinical signs:
- Ataxia, lateral/prone position and hyporeflexia
- Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 760 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Five rats were exposed to an vapour-air mixture for 4h, 14 days observation period following administration.
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- other: Please refer to principles of method if other than guideline
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- The vapour-air mixture is generated by passing 2.5 litres/minute of dried air at room temperature through a fritted glas disc immersed to a depth of at least one inch in approximately 50 mL if the test chemical contained in a gas-washing bottle.
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 4000 ppm
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 000 ppm
- Based on:
- test mat.
- Remarks on result:
- other: 4000 ppm corresponding to approximately 16207 mg/m³
- Mortality:
- 0/5 animals died
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 16 207 mg/m³
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Four rabbits were exposed to the test item for 24 hours by an occlusive clip. The observation period was 14 days.
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- other: Please refer to principles of method if other than guideline
- Species:
- rabbit
- Strain:
- other: New Zealand
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Weight: 2.5 to 3.5 kg
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- - Fur is removed by clipping
- Dose is retained beneath an impervious plastic film
- The animals are immobilized during the 24-hour contact period - Duration of exposure:
- 24 hour followed by a 14-day observation period
- Doses:
- no data
- No. of animals per sex per dose:
- four
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.41 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: corresponding to 1354 mg/kg bw
- Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 354 mg/kg bw
Additional information
Acute oral toxicity
Key study
A study (Hoechst AG, 1968) was performed to assess the acute oral toxicity of the test substance to the rat. A group of ten rats (females) was given a single dose by oral gavage of the test substance, formulated in 1 % aqueous solution, at a dose level of 800, 1250, 2000,3200 and 5000 mg/kg bw. After administration a 7 day observation period followed. One animal at 1250 mg/kg group, eight animals at the 2000 mg/kg bw group and all animals at the 3200 and 5000 mg/kg bw group died within 100 min – 48 hours and three males and all females at 5000 mg/kg died during the study. Death was accompandied by ataxia, lateral/prone position and hyporeflexia. The LD50 value was determined at 1760 mg/kg bw.
Acute toxicity inhalation
Key study
In an inhalation toxicity study (Smyth, 1962) five male rats were administered with the vapour-air mixture of the test substance in a concentration of 4000 ppm for 4 hours. The vapour-air mixture is generated by passing 2.5 litres/minute of dried air at room temperature through a fritted glas disc immersed to a depth of at least one inch in approximately 50 mL if the test chemical contained in a gas-washing bottle. The treated animals were observed for fourteen days. The acute lethal dermal dose of the test substance was found to be greater than 4000 ppm (corresponding to approximately 16207 mg/m³).
Acute dermal toxicity
Key study
A study (Smyth, 1962) was performed to assess the acute dermal toxicity of the test substance to five rabbits. Fur was removed by clipping and the test item was retained beneath an impervious plastic film. Animals were immobilized during the 24-hour contact period. The LD50 value was determined to be 1.41 mL/kg bw (corresponding to 1354 mg/kg bw).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available data are reliable and suitable for classification purposes under Regulation 1272/2008. The acute oral LD50 was determined to be 1760 mg/kg bw. As a result the substance is considered to be classified for acute oral toxicity Category 4 (H302: harmful if swallowed) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
The acute dermal LD50 was determined to be 1354 mg/kg bw. As a result the substance is considered to be classified for acute dermal toxicity Category 4 (H312: harmful in contact with skin) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
No mortality was observed at 16207 mg/m^3. As a result the substance is not considered to be classified for acute inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
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