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Diss Factsheets
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EC number: 274-977-9 | CAS number: 70880-03-4
- 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
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 28th July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- water
- Details on test system:
- The reconstructed human epidermal model EpiDerm (EPI-200, MatTek, Ashland, USA) consists of normal human epidermal keratinocytes which have been cultured to form a multilayered highly differentiated model of the human epidermis. The EpiDerm System is manufactured according to defend quality assurance procedures.The EpiDerm tissues (surface 0.63 cm2) are cultured on specially prepared cell culture inserts and shipped as kits containing 24 tissues on shipping agarose together with the necessary amount of culture media.
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test substance was placed directly atop to the previously moistened tissue with 25 µL water. The material was spread on the tissue surface.
- Duration of treatment / exposure:
- 3 min, 60 min
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 92.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 90.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: not corrosive to skin
- Conclusions:
- Under experimental conditions, the test substance, Reactive Violet 1, is not corrosive in In vitro Skin Corrosion Test on EpiDerm tissues.
- Executive summary:
The test substance, Reactive Violet 1,was assayed for the in vitro skin corrosion in human epidermal model EpiDerm. The test was performed according to OECD Test Guideline 431, In vitro Skin Corrosion: Human Skin Model Test, adopted in July 28th, 2015.
Direct reduction test in test tubes was performed before MTT test. As the test substance is coloured violet, the test gave no information about direct MTT reduction. Potential direct reduction caused by rests of the test substance in tissues was excluded after the test in frozen tissues.
In MTT test, the test substance (25 mg) was placed directly atop to the previously moistened tissue. Length of exposition was 3 and 60 minutes. Nine tissues were used for the experiment in each time, three per test substance, three for positive control, three for negative control. After rinsing tissues were incubated with MTT for three hours and then extracted with isopropyl alcohol for two hours at room temperature with shaking. OD(570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as per cent of the mean viability of the negative control tissues.
Under experimental conditions, average reactivity of tissues treated by the test substance, Reactive Violet 1, was 92.1 % of the negative control after 3 minutes treatment and 89.6 % (after correction) after 60 minutes treatment. According the test conditions, the test substance is not corrosive in In vitro Skin Corrosion Test on EpiDerm tissues.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards and acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g per animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not classified
- Conclusions:
- Practically non-irritating to intact skin; very slightly irritating to scarified skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards and acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied: 0.1 g
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1/10 corneal surface opaque
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 3
- Interpretation of results:
- not classified
- Conclusions:
- Based on level of eye damage, the test substance, Reactive Violet 1, has not been classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the skin and eye irritation/corrosion test results, the test substance is not irritating to eyes and skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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