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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
- 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 LD 50 of the test substance for the acute oral toxicity is greater than 2000 mg/kg bw.
The LD 50 of the test substance for the acute dermal toxicity is greater than 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 April 10th to May 1st, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- July 31st, 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- February 24th, 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Stable in a 1:1 mixture of PEG/water for 48 hours
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: bidistilled water:PEG 400 = 1:1
- Details on oral exposure:
- Dosage after 16 hours fasting, but free access to water. Food was provided approximately 3 hours after dosing.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male rats, 5 female rats
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths as a result of treatment with the test substance.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the observation period.
- Gross pathology:
- No macroscopic findings were observed at necrospy.
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 2000 mg/kg
- Executive summary:
The acute toxicity of the test material was investigated following oral administration of a single dose to the rat, according to the OECD Guideline 401.
The test substance was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg.
The following death rate was observed:
0% at 0 mg/kg (control group)
0% at 2000 mg/kgNo clinical signs of toxicity were observed during the observation period.
The acute oral LD50 of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be greater than 2000 mg/kg.
Reference
The mean lethal dose of the test substance after single oral administration to rats of both sexes, observed for a period of 14 days, could not be estimated because LD50 > 2000 mg/Kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
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 April 30th to May 21st, 1996
- 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:
- February 24th, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- July 31st, 1992
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
- Specific details on test material used for the study:
- Stable in a 1:1 mixture of PEG/water for 48 hours
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- other: other: bidistilled water:PEG 400 = 1:1
- Details on dermal exposure:
- Clipped area on the back of animals corresponding to ca. 10 % of the total body surface.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male rats, 5 female rats
- Control animals:
- no
- Details on study design:
- Observations up to day 15.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred.
- Clinical signs:
- other: There were no clinical signs of sistemic toxicity.
- Gross pathology:
- No macroscopic findings were noted at necropsy.
- Other findings:
- After removal of the dressing on test day 2, a blue coloration of the skin was observed at the application site of all animals. The staining persisted until test day 7.
- Interpretation of results:
- other: Not classified within the CLP Regulation (EC 1272/2008).
- Conclusions:
- LD50 > 2000 mg/kg
- Executive summary:
The acute toxicity of the test material was investigated following dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semiocclusive dressing. Animals were observed up to day 15. After 14 days, all animals were killed and subjected to necropsy examination.
No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. No significant abnormalities were found at necropsy in the animals at termination of the study.
LD50 > 2000 mg/kg
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
The acute toxicity of the test material was investigated following oral administration of a single dose to the rat, according to the OECD Guideline 401.
The test substance was administered to rats of both sexes by oral gavage, at a dose of 2000 mg/kg.
The following death rate was observed:
0% at 0 mg/kg (control group)
0% at 2000 mg/kg
No clinical signs of toxicity were observed during the observation period.
The acute oral LD50 of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be greater than 2000 mg/kg.
The acute toxicity of the test material was investigated following dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semiocclusive dressing. Animals were observed up to day 15. After 14 days, all animals were killed and subjected to necropsy examination.
No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. No significant abnormalities were found at necropsy in the animals at termination of the study.
LD50 > 2000 mg/kg
Justification for classification or non-classification
The CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.1.1 gives the following criteria for acute oral and dermal toxicity: "Category 4: 300 < ATE ≤ 2000," where ATE is acute toxicity estimates in mg/kg bodyweight.
Based on the test material, LD50 was determined to be > 2000 mg/kg bw both for oral and dermal exposure therefore, the test substance is not classified for acute toxicity.
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