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EC number: 433-240-3 | CAS number: -
- 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 did not produce any adverse effects after dermal as well as oral administration to rats.
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 17 AUG 1999 to 07 SEP 1999
- 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)
- Version / remarks:
- 22 MAR 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 SEP 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: females 10 weeks, males 8 weeks
- Body weights at study initiation: females 161.7, 180.1, 181.1 g, males 223.9, 214.3, 218.8 g
- Fasting period before study: overnight 16-16.5 h
- Housing: groups of three in Makrolon type-4-cages with standard softwood bedding
- Diet: pelleted standard Kliba 3433, batch no. 39/99 rat maintainace diet, ad libitum
- Water: Community tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL - 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: weighing on test day 1 (pre-administration), 8 and 15, observations four times during test day 1, once daily from day 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: observation of changes in appearance and behaviour - Statistics:
- No statistical analysis was done as no death occurred.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: exact LD50 not determinable due to absence of adverse toxic effect
- Mortality:
- No deaths occurred.
- Clinical signs:
- No clinical sign were observed.
- Body weight:
- Body weight was in the normal range of animals of this strain and age
- Gross pathology:
- No effects observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in 3 male and 3 female HanIbm: WIST rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
- Executive summary:
3 Male and 3 female rats (HanIbm: WIST) were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw in polyethylene glycol. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable
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 31 AUG 1999 to 21 SEP 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 FEB 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31 JUL 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: females 12 weeks, males 9 weeks
- Weight at study initiation: females between 186.1 and 208.6 g, males between 207.0 and 255.5 g
- Fasting period before study: no
- Housing: during treatment and observationindividually in Makrolon type 3 cageswith standard soft bedding
- Diet: pelleted standard Kliba 24-3433-4, batch no. 39/99 rat maintainace diet, ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.0 mL/ kg bw
- Concentration (if solution): 33% [w/v]
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations four times during test day 1 and once daily during days 2-15, weighing on test day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic findings - Statistics:
- No statistical analysis was used as no deaths ocurred.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: exact LD50 not determinable due to absence of adverse toxic effect, no indication of skin irritation up to the relevant limit dose level.
- Mortality:
- No deaths ocurred during the study.
- Clinical signs:
- Yellow staining and test article remnants on the application site were observed. Yellow staining persisted in two males and three females until day 13.
- Body weight:
- Body weights were within the range commonly recorded for animals of this strain and age.
- Gross pathology:
- No macroscopic findings were observed at necroscopy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single dermal application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in 5 male and 5 female HanIbm: WIST rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
- Executive summary:
5 Male and 5 female rats (HanIbm: WIST) were subjected to test acute dermal toxicity according to the acute dermal toxicity test method (OECD TG 402, limit test). The test substance was applied semiocclusively to the animals backs at the limit dose of 2000 mg/kg bw in propylene glycol. After 24 h the test substnce was removed, the skin was washed clean and the animals were observed for 14 days. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw. No skin irritation was observed either.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable
Additional information
Justification for classification or non-classification
No classification
The test item did not produce any adverse effects after dermal as well as oral administration to rats.
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