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EC number: 440-520-9 | CAS number: 204583-39-1
- 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 test item was applied oral and dermal to rats to evaluate the acute toxicity of the substance (GLP, OECD 423 and 402).
LD50 after oral administration > 2000 mg/kg bw. Signs of toxicity were not observed. LD50 after dermal application> 2000 mg/kg bw. Signs of toxicity were not observed. A test on acute inhalative toxicity was not performed.
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:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanBrl: Wist (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fuellinsdorf / Switzerland- Age at study initiation: males = 8 weeks, females = 10 weeks- Weight at study initiation: males = 187.7 - 210.4 g, females = 181.5 - 184.9 g- Fasting period before study: 16 to 20 hours- Housing: three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 77/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland) ad libitum.- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum- Acclimation period: one weekENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/12 hours dark
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE- Lot/batch no. (if required): 430424/1 54701 (animal nos. 1-3), 430424/1 25001 (animal nos. 4-6)MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical signs were noticed daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded. Weighing was done on test days 1 (pre-administration), 8 and 15.- Necropsy of survivors performed: yes
- Statistics:
- Not necessary
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- other: No clinical signs were noted during the course of the study.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fuellinsdorf / Switzerland- Age at study initiation: males = 8 weeks, females = 7-8 weeks- Weight at study initiation: males = 215.9 - 233.9 g, females = 180.1 - 210.7 g- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 57/02 (Provimi Kliba AG, Kaiseraugst/ Switzerland) ad libitum.- Water (e.g. ad libitum): Community tap water from Fuellinsdorf ad libitum.- Acclimation period: one weekENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on dermal exposure:
- TEST SITE- % coverage: approximately 10 % of the total body surfaceREMOVAL OF TEST SUBSTANCE- Washing (if done): with lukewarm tap water- Time after start of exposure: Twenty-four hours after the application.TEST MATERIAL- Amount(s) applied (volume or weight with unit): 6.66 g/kg bw- Concentration (if solution): 30 %
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical signs were noticed daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. Weighing was done on test days 1 (prior to administration), 8 and 15. Mortality / Viability was notice daily during acclimatization and twice daily during days 1-15.- Necropsy of survivors performed: yes, at the end of the observation period
- Statistics:
- No statistical analysis was used.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
There are reliable studies available to assess the acute oral and dermal toxicity of the test substance.
A GLP conform study was performed to assess the acute toxicity following oral administration of the test substance in HanBrl: WIST rats according to OECD guideline 423 (RCC Ltd, 2002). To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation (dose volume: 10 ml/kg bw) in PEG 300 at a dose level of 2000 mg/kg body weight was given. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.
A GLP conform study was performed to assess the acute toxicity following dermal administration of the test substance in HanBrl: WIST rats according to OECD guideline 402 (RCC Ltd, 2002). Five male and five female rats were treated with the test substance (purity: 98.4 weight-%; dose volume: 6.66 g/kg bw) at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 30 % (w/w) and administered at an amount dosage of 6.66 g/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Under the conditions of this study the median lethal dose of the test substance after dermal application was found to be greater than 2000 mg/kg body weight for the male and female animals.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008. Based on this data the substance does not need to be classified for acute toxicity under Regulation (EC) No. 1272/2008.
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