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EC number: 224-166-0 | CAS number: 4221-80-1
- 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
The oral LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths occurred at any dosage levels used. The LC50 by inhalation in male and female rats exposed to the substance for four hours is greater than 500 mg/m³, air. The dermal LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths were caused by the test substance and no outward symptoms of toxicity were observed.
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
- Remarks:
- Only short summary available, but results are reported sufficiently for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspension of dimethylsulfoxide/propylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg
DOSAGE PREPARATION:
The test substance was prepared as a suspension in 25 % dimethylsulfoxide/75% propylene glycol, containing the compound at a concentration equivalent to 2500 mg/kg. The 5000 mg/kg level was attained by dosing with 2 times the volume at 2500 mg/kg; 10000 mg/kg by dosing twice at 5000 mg/kg with a 3 hr interval between doses. - Doses:
- 1250, 2500, 5000 and 10000 mg/kg
- No. of animals per sex per dose:
- 5 animals per group (sex not specified)
- Control animals:
- not specified
- Details on study design:
- no data
- Preliminary study:
- none
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was greater than 10000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- No guideline study but acceptable for assessment
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:
- 1973
- 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)
- Version / remarks:
- 2009
- Deviations:
- yes
- Remarks:
- Oberservations for only 7 days and not for 14 days, only one concentration level tested.
- Principles of method if other than guideline:
- Oberservations for only 7 days and not for 14 days, only one concentration level tested.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Own breeding unit
- Age at study initiation: Animals used were 8-9 weeks old
- Weight at study initiation: 195-200 g
- Fasting period before study: not given
- Housing: Segregated by sex and kept in Macrolon cages, type 4 (9 animals to a cage)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- °C
- Humidity: 50 % - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Pressure nozzle
- Exposure chamber volume: 10L/min.
- Method of holding animals in test chamber: Kept in separate PVC tubes positioned radially around the exposure chamber.
- Source and rate of air: Compressed air (2 atm.)
- System of generating particulates/aerosols: A 20 % suspension in ethanol of the test substance was injected by a motor-driven syringe at a rate of 60 mL/h into a stream of compressed air flowing through a spray nozzle at a rate of 10 L/min.
TEST ATMOSPHERE
- Brief description of analytical method used: The aerosol was sampled on Membrane Filters, pore size 0.2 µm (Satorius, 34 Göttingen, Germany) in the immediate vicinity of the animals hourly after the beginning of the test.
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle: A 20 % suspension of the test article in ethanol was sprayed into the exposure chamber
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle-size distribution in the aerosol was determined gravimetrically on Selectron-Filters, pore size 0.2 µm (Schleicher and Schuell, 8714 Feldbach, Switzerland) every hour with the aid of a "Cascade Impactor" (CT. Casella and Co. Ltd., London N.l, England). Results:
> 7 µm = ca. 6%
3-7 µm = ca. 12%
1-3 µm = ca. 35%
< 1 µm = ca. 48% - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetrically
- Duration of exposure:
- 4 h
- Concentrations:
- 448 +/- 37 mg/m3 (highest possible concentration)
- No. of animals per sex per dose:
- 9 female
9 male - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: 0-4 h, 24 h, 48 h, 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology - Preliminary study:
- none
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 500 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: no higher concentrations possible
- Mortality:
- no mortality
- Clinical signs:
- other: The rats showed lateral position and apathy after 4h.
- Body weight:
- not measured
- Gross pathology:
- No substance related gross organ changes were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 of the test material determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 500 mg/m3 air.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 500 mg/m³
- Quality of whole database:
- Comparable to guideline requirements
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only short summary available, but results are reported sufficiently for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Vehicle:
- other: xylene
- Details on dermal exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg
VEHICLE
- Amount(s) applied: Small quantity of xylene was used as a binder to allow better application of the test substance to the clipped skins areas - No. of animals per sex per dose:
- No of animals: 3 animals per dose (sex not specified)
- Control animals:
- not specified
- Details on study design:
- no data
- Preliminary study:
- none
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 was greater than 10000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- No guideline study but acceptable for assessment
Additional information
Acute toxicity: oral route
An acute oral toxicity study was performed to assess the range of mortality following oral administration of the test material. The nominal concentrations tested were: 1250, 2500, 5000 and 10000 mg/kg body weight. The LD50 was determined to be greater than 10000 mg/kg body weight. Responses to the administered test substance were negligible. No deaths occurred at any dosage levels used. In addition, in a 28d oral repeated dose toxicity study, no deaths were reported upon daily administration of > 2000 mg/kg body weight in feed. Therefore, it can be concluded that the test compound does not possess any acute toxic potential by the oral route.
Acute toxicity: inhalation route
Aim of the study was to provide information on health hazards likely to arise from short-term exposure by the inhalation route. The test substance was tested by the exposure of male and female albino rats to an aerosol generated from this product. A 20% suspension of the test article in ethanol was tested at a concentration of 448 +/- 37 mg/m³. No higher concentrations were possible. The LC50 of the item determined after an observation period of 7 days in rats of both sexes, exposed to the substance for four hours is greater than 500 mg/m³ air. No deaths occurred, the only clinical symptom was lateral position and apathy from which all animals had recovered within 24 hours. No changes were noted during autopsy.
Acute toxicity: dermal route
A study was performed to assess the range of mortality following dermal administration of the test material. A concentration of 10000 mg/kg body weight was tested. The LD50 was determined to be greater than 10000 mg/kg body weight. No deaths were caused by the test substance and no outward symptoms of toxicity were observed.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral, dermal or inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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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