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Diss Factsheets
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EC number: 939-379-0 | 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
Valid studies for acute oral toxicity according OECD 401 and acute inhalation toxicity according OECD 403 are available.
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:
- other: scientifically acceptable and well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
Five male and five female Wistar rats (158-182 g) received a single dose of 5000 mg/kg bw of Bayplast Gelb 5G per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals sacrificed at the end of the 14 days observation period.
No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced. None of the animals sacrificed at the end of study showed any noticable gross pathological findings.
LD50 > 5000 mg/kg bw (rat, male + female)
Reference
No signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced.
None of the animals sacrificed at the end of study showed any noticable gross pathological findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0, 5222 mg/m³
- No. of animals per sex per dose:
- control group: 5 male and 5 female ratstest group: 3 male and 3 female rats
- Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 5 222 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Executive summary:
A study on the acute inhalation toxicity of Gelbpigment E4GN on rats has been conducted in accordance with OECD TG#403 (2009). Test procedures were adapted so as to comply also with the EU Directive 92/69/EEC, and especially OECD GD#39 (2009). One group of 3 male and 3 female Wistar rats was nose-only exposed to the dry powder aerosol of Gelbpigment E4GN atat an actual concentration of 5222 mg/m³ for 4 hours. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed. The aerosol was generated so that it was respirable to rats. The results can be summarized as follows:
LC50(inhalation, 4h) -males&females: > 5222 mg/m³
Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m3. Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.
In summary, the aerosolized test substance (solid aerosol) proved to have essentially no acute inhalation toxicity in rats.
Reference
Mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m³.
Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.
The respirability of the aerosol was adequate to achieve the objective of study, i.e. the average mass median aerodynamic diameter (MMAD) was 2.8 µm, the average geometric standard deviation (GSD) was 2.7.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 222 mg/m³ air
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the acute oral toxicity study no signs of intoxication were seen after the application of 5000 mg/kg bw to male and female rats. None of the animals died. Weight gain was not influenced. None of the animals sacrificed at the end of study showed any noticable gross pathological findings.
In the acute inhalation toxicity study mortality did not occur up to the maximum technically attainable concentration of 5222 mg/m³.
Clinical observations revealed the following sings: Irregular breathing patterns, labored breathing patterns, high-legged gait, atony, piloerection, and motility reduced, hypothermia, and transiently decreased body weights. Towards the end of the first postexposure week all rats appeared to be indistinguishable from the control.
Justification for selection of acute toxicity – oral endpoint
only available study
Justification for selection of acute toxicity – inhalation endpoint
only available study
Justification for classification or non-classification
Due to the results of the acute oral toxicity study (LD50 > 5000 mg/kg bw) and the acute inhalation toxicity study (LC50 > 5222 mg/m³) a classification is not justified.
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