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EC number: 238-238-4 | CAS number: 14302-13-7
- 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
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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- ; the study was conducted with mice (rat is the standard species, recommended in OECD guideline 401).
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Lionol Green 6YK
- Analytical purity: no data given
- Substance type: fine green powder
- Storage condition of test material: at ambient temperature - Species:
- mouse
- Strain:
- other: HC/CFLP (ICI strain 1)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Ltd., Huntingdon, Cambridgeshire, UK
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 18 - 23 g
- Fasting period before study: overnight prior to and approx. 4 h after dosing
- Housing: allocation to cages within the treatment group; housing in plastic cages with sawdust bedding
- Diet: standard laboratory rodent diet (Scientific Feeds LAD 1 obtained from Special Diet Services Ltd., Witham, Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 64 %
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Concentration of the test material in vehicle:
- 40 % w/v suspension
- Amount of test material applied per gavage:
- 40 ml/kg bw for 16000 mg/kg bw
The control animals were treated with vehicle alone. - Doses:
- 0 and 16000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose.
- Control animals:
- yes
- Details on study design:
- Animals were observed soon after dosing; then at frequent intervals for the remainder of day 1, On subsequent days the animals were observed at least twice. Clinical signs were recorded at each observation.
All animals were observed for 14 days after dosing and the nature, severitx, approx. time of onset and duration of each toxic sign were recorded.
Individual body weights were recorded on day of dosing (day 1) and on days 8 and 15.
All animals were killed on day 15 and were subjected to a macroscopic post mortem examination. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.
- Gross pathology:
- Terminal autopsy revealed no findings.
- Interpretation of results:
- GHS criteria not met
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
There are valid data available for the assessment of the acute oral toxicity of a commerical form of CAS 14302 -13 -7. The study was performed under the Quality Auditing scheme, but a GLP-certificate is not part of the study report. The procedure is consistent with OECD testing guideline 401, but the tested dose of 16 000 mg/kg bw exceeds the limit dose of 2000 mg/kg bw which is required in the EU for classification and labelling. Since no mortality occurred at this excessive high dose, this study can be used as key study despite the lack of purity information. In a limit test each five HC/CFLP male and female mice were administered to single doses of 0 or 16000 mg/kg bw (Huntingdon 1984, Val.2). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.
In the absence of acute oral toxicity at the limit dose and considering the insolubility, testing for acute dermal toxicity is not required. The pigment is considered to be non toxic at the limit dose in the acute dermal toxicity study.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at 16000 ,mg/kg bw which exceeds the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal or inhalation toxicity under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.
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