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EC number: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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 two limit test studies via oral and dermal routes, according to international OECD guidelines: LD50 > 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:
- From May 15th to May 31st
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: 8 weeks for males, 10 weeks for females.
- Housing: 3 per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted stabdard Kliba 3433, batch no. 07/00 rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0,2 g/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test for EU CLP classification - 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:
Mortality/viability: daily during acclimation, twice daily during days 1-15
Body weights: on test day 1 (pre-administration), 8 and 15
Clinical signs: daily during acclimation, four times on day 1, once daily dusign days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - 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 clinical signs were noted during the course of the study
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- other: EU CLP criteria not met
- Conclusions:
- The median lethanl dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50(rat) > 2000 mg/kg bw - Executive summary:
A group of three male and three female HanBrl: Wist(SPF) rats was treated with substance at 2000 mg/kg bw by oral gavage. The test item was diluted in vehicle (bi-distilled water) at a concentration of 0,2 g/mL and administered at a volume of 10 mL/Kg. The animals were examined for clinical signs daily during acclimation, four times during test day 1 and once daily during test days 2 -15. Mortality/viability was recorded together with clinical signs at the same time intervals during acclimation, day 1 and 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.
No deaths occurred during the study. 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. Therefore, LD50 of the substance was determined to be greater than 2000 mg/Kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- 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:
- From May 2nd to May 16th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanCrl: Wist Han (Glx. BRL)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 9 weeks for males, 11 weeks for females
- Housing: 5 per sex in Makrolon type-4 cages with standard softwood bedding during acclimation. Individually in makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet (e.g. ad libitum): Pelleted stabdard Kliba 3433, batch no. 07/00 rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the total body surface
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/Kg bw
- Concentration (if solution): 0,5 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- 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 examined 4 times during test (Day 1), once daily during observation period (Day 2-15). Weighing on Day 1 prior to administration, then on Day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology. - 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: Slight focal erythema was noted in animal no: 3,5,6,8 and 10 at the second observation day and was considered to be a test item-related non toxic effect. Slight scale skin was noted in female no. 6 at the third obsrvation day and was considered to be inc
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- other: EU CLP criteria not met
- Conclusions:
- The median lethanl dose of the substance after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50(rat): > 2000 mg/kg bw - Executive summary:
A group of five male and five female HanCrl: Wist Han (Glx. BRL)BR rats was treated with substance at 2000 mg/kg bw by dermal application. The test item was diluted in vehicle (bi-distilled water) at a concentration of 0,5 g/mL and administered at a volume of 4 mL/Kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15. Mortality/viability was recorded together with clinical signs at the same time intervals during day 1. During test days 2 -15 it was recorded two times a day. 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. Slight focal erythema was noted in animal no: 3,5,6,8 and 10 at the second observation day and was considered to be a test item-related non toxic effect. Slight scale skin was noted in female no. 6 at the third obsrvation day and was considered to be incidental. All other animals were without findings. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Therefore, LD50 of the substance was determined to be greater than 2000 mg/Kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
In two limit test studies via oral and dermal routes, according to international OECD guidelines: LD50 > 2000 mg/Kg bw.
Therefore, according to EU CLP criteria the substance should not be classified for acute toxicity via oral or dermal route.
No data are available for acute inhalation toxicity and a specific study was not performed.
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