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EC number: 226-789-3 | CAS number: 5468-75-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Male and female Tif. RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at dose levels up to the highest applicable dose of 10000 mg/kg bw. No animal died under these conditions, thus leading to a LD50 > 10000 mg/kg bw. No substance related gross organ changes were seen at necropsy.
Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.
Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (e.g. only 7 days post observation period, no details on body weight development)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : only 7 days of observation p.a.; details on body weight development are missing
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF in-house breeding colony
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180g
- Fasting period before study: one night before treatment
- Housing: caged in Macrolon cages (type 3) in groups of five (male and female separately)
- Diet: ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% suspension in 2% CMC - Doses:
- 6000 and 10000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Remarks on result:
- other: no animals died within the observation period
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- Single application of different dose levels ( up to 10 g/kg bw) of the test substance did not cause lethality in male and female Tif. RAI rats during the 7 day observation period, resulting in a LD50 > 10000 mg/kg bw.
- Executive summary:
Male and female Tif. RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at dose levels up to the highest applicable dose of 10000 mg/kg bw. No animal died under these conditions, thus leading to a LD50 > 10000 mg/kg bw. No substance related gross organ changes were seen at necropsy.
Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please, see read across document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Remarks on result:
- other: no animals died within the observation period
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- Single application of different dose levels ( up to 10 g/kg bw) of the test substance did not cause lethality in male and female Tif. RAI rats during the 7 day observation period, resulting in a LD50 > 10000 mg/kg bw.
- Executive summary:
Male and female Tif. RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at dose levels up to the highest applicable dose of 10000 mg/kg bw. No animal died under these conditions, thus leading to a LD50 > 10000 mg/kg bw. No substance related gross organ changes were seen at necropsy.
Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.
Referenceopen allclose all
- within 2 hours after treatment, all treated animals showed dyspnoea, exophthalmus, curved position and ruffled fur
- in the higher dose (10 g/kg bw) these symptoms became more accentuated
- all animals recovered within 3 to 6 days
- animals were sacrificed at day 7, but no substance related gross organ changes were seen
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- reliable with restriction: read across
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- : 10 hrs light cycle, some exposure data are missing (e.g. MMAD (not calculated), equilibration period)
- GLP compliance:
- no
- 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: in house breeding, SPF breeding colony
- Weight at study initiation: 170 - 190 g
- Housing: in Macrolon cages (type 4) in groups of 10, males and females separated
- Diet: NAFAG (Gossau SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 55+/-5
- Photoperiod: 10 hrs light cycle day - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation cylinder
- Method of holding animals in test chamber: seperate PVC tubes
- System of generating aerosols: Injecting the solid material with the help of "Grafix Exactometer injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: gravimetrically
- Temperature, humidity, oxygen: 24 °C, 38%, 20 Vol.%
TEST ATMOSPHERE
- Brief description of analytical method used: Concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 17.5 L/min.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: < 1 µm to > 7 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- : gravimetric measurement
- Duration of exposure:
- 4 h
- Concentrations:
- 4250 (+/-128) mg/m³
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 250 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: no animals died within the 14 day observation period
- Mortality:
- - no death occurred
- Clinical signs:
- other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
- Gross pathology:
- - no macroscopically visible changes were found
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
- Executive summary:
Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.
Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see read across justification document on Chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 250 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: no animals died within the 14 day observation period
- Mortality:
- - no death occurred
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
- Executive summary:
Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.
Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Physical form:
- inhalation: dust / mist
- Quality of whole database:
- reliable with restriction: read across
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable with restriction: read across
Additional information
Justification for classification or non-classification
No classification
No adverse effects were observed after acute oral d3eremal or inhalation exposure.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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