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EC number: 206-490-4 | CAS number: 349-76-8
- 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 toxicity: oral
Groups of 5 male and 5 female rats were administered a single dose of the undiluted test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 2000 mg/kg body weight.
Acute toxicity: inhalation
Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings.
Acute toxicity: dermal
Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 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:
- July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Stability under test conditions:
no information available
- Solubility and stability of the test substance in the solvent/vehicle: no information available
- Treatment of test material prior to testing: no information available
- Final dilution of a dissolved solid, stock liquid or gel: 5999 mg test article with vehicle ad 30 ml (no further information (e.g. on correction factor) available - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 7-11 weeks
- Weight at study initiation: approx. 154-191 g
- Housing: Macrolon Type 4 cages; 5 same-sex animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): ca. 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5999 mg test article with vehicle ad 30 ml
- Volume applied: 10 ml/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment.
- Gross pathology:
- Necropsy examinations revealed no observable abnormalities.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Groups of 5 male and 5 female rats were administered a single dose of the formulated test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 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:
- Only one study available
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- July - September 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1996 ("Public Draft")
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Stability under test conditions: Considered to be stable
- Preparation of test articel: The test article was used as supplied by the Sponsor. The test aerosol was generated in ambient conditions using a nebuliser connected to a syringe pump. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-10 weeks
- Weight at study initiation: approx. 193-227 g
- Housing: Macrolon Type 4 cages; 5 same-sex animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): between 50 -80
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Remarks:
- flow-past exposure
- Vehicle:
- air
- Remark on MMAD/GSD:
- Attempts to measure particle size during the exposure produced faulty and unrepresentative results, because of evaporation of the test article, and consequently condensation inside the impactor used for measuring particle size. Therefore particle size data and a mean mass aerodynamic diameter (MMAD) were not reported.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- target concentration 5 mg/l air
Achieved concentrations:
- Nominal: 9.217 mg/l air
- Gravimetric: 5.287 mg/l air
- Analytical: 6.913 mg/l air - No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- The LOGIT-Model was not used as only one group was exposed and there were no deaths.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 6.913 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: analytical mean value
- Remarks:
- with a standard deviation of +- 0.472 mg/l air
- Mortality:
- no deaths occured
- Clinical signs:
- other: The principal clinical signs observed were the findings of ruffled fur, decreased spontaneous activity and uncoordinated movements/gait. From the nature and severity of these clinical signs, systemic exposure of the animals to the test article was conclud
- Body weight:
- Body weights were not affected in male animals. A slight, transient retardation in mean body weight gain of female animals from test day 1 (prior to exposure) to test day 4 may have been treatment-related.
- Gross pathology:
- There were no macroscopical pathology findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC 50 of the test item was estimated to be greater than 6.913 mg/l air (analytical mean value), as no deaths occured.
- Executive summary:
Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 6 913 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- August 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanIbm:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Biotechnology & Animal Breeding Division, Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: approx. 213-240 g
- Housing: individual (Macrolon Typ 3 cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): between 50 +/- 20
- Air changes (per hr): 13-14
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10 of body surface
- Type of wrap if used: Isocomfort self-adhesive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 400 mg per 100 g bw
- Concentration (if solution): 5011 mg with 5000 mg vehicle
- Duration of exposure:
- 14-day post-treatment observation period
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females rats
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: No remarkable clinical observations.
- Gross pathology:
- No observable abnormalities.
- Other findings:
- No remarkable findings at the application site.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Based on the study results for acute toxicity (oral, inhalation, dermal) no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
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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