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EC number: 204-905-3 | CAS number: 128-69-8
- 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
Skin irritation/corrosion: non-irritating, compareable to OECD TG 404, non-GLP, application of test substance in water (50%), rabbit, 1976, K2
Eye irritation: non-irritating, compareable to OECD TG 405, non-GLP, 50 mg of the test substance, rabbit, 1972, K2
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- only a 50% aqueous substance preparation was tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- A 50% aqueous preparation of the mixture has been applied on the back of rabbits for 20 hours, observations were reported after 24, 48, 72 hours and after 6 and 8 days.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Physical state: solid
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2,49 kg and 2,84 kg - Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- - Concentration (if solution): 50% aqueous preparation
- Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2,5 x 2,5 cm on the backs
- Substance was applied with a cotton tissue soaked with the test article.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm tap water
- Time after start of exposure: 20 h after application - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 8 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Until day 6 scoring for erythema was not possible due to the skin coloring.
- Irritant / corrosive response data:
- The test article did not cause apparent dermal reactions, however the exact determination of erythema scores at 24, 48 and 72 hours was not possible due to coloring by the test substance. Remaining colored test substance was observed until day 8. No edema was reported at all time point. From the 6 days observation time point, no erythema were reported. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). The test item was found to cause no irritation when applied to intact rabbit skin.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be not irritating to skin.
- Executive summary:
In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the rabbit skin on the back. Remaining colored test substance was observed at both observation time points (24 hours and 8 days). No edema was reported at the 24 hours observation time point. At this time point, scoring for erythema was not possible (due to skin coloring). At the 8 days observation time point, no edema and erythema were reported. The test substance was considered to be not irritating.
Reference
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The substance is applied in the eye of the rabbit undiluted (1x 50 mm3 / 50 mg). Observations are recorded 1 hour, 24 hours, 48 hours, 5, 7 and 8 days after application.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Physical state: solid
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2,71 and 2,46 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum powder applied into the left eye served es control.
- Amount / concentration applied:
- 1x 50 mm^3 / 50 mg
- Duration of treatment / exposure:
- one single appliaction into the right eye
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- The substance is applied in the right eye of the rabbit undiluted (1x 50 mm3 / 50 mg).
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 1 hour after application, slight reddening of the conjunctivae and secretion was observed. These effects reverted back to normal within one day in animal number 1. In the second animal, the reddening also reversed to normal after one day, but reappeared on day 2 and persisted until day 7. On day 8 both animals were free of any irritational signs. The eyes were also dyed dark red by the substance. The initial slight signs of irritation were comparable with the effects of the control, talcum powder, in the eyes of rabbits. However the effects of talcum powder in rabbit eyes were becoming stronger after 24 hours, while the effects of the substance have disappeared. After 8 days also the effects of the talcum powder have disappeared.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found not to be irritating to eyes.
- Executive summary:
In a non-GLP study according to a method comparable to OECD guideline 405, 50 mg the test substance was applied undiluted into the right eye of two rabbits. The left eyes were treated with talcum powder and served as control. One hour after application, slight reddening and secretion were reported. These effects were reversible within 24 hours. The eyes were also dyed dark red by the substance. The control eyes showed redness of the conjunctivae and slight edema, the redness was still present at the 24 hour time point and completely resolved after 8 days. The substance was considered to be not irritating to the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the rabbit skin on the back (BASF, 1976). Remaining colored test substance was observed at both observation time points (24 hours and 8 days). No edema was reported at the 24 hours observation time point. At this time point, scoring for erythema was not possible (due to skin coloring). At the 8 days observation time point, no edema and erythema were reported. The test substance was considered to be not irritating.
In a supporting non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the back and the ear of two rabbits (BASF, 1972). At the observation time points 24 hours and 8 days, red/brown remains of the substance on the skin were observed, but no irritative/corrosive response. The test substance was found to be not irritating.
Eye irritation
In a non-GLP study according to a method comparable to OECD guideline 405, 50 mg of the test substance was applied undiluted into the conjunctival sac of the right eye of two rabbits (BASF, 1972). The left eyes were treated with talcum powder and served as controls. One hour after application, slight erythema, slight edema and slight cloudiness of the cornea were observed. The eyes were also dyed by the substance. After 24 hours the eyes showed still some slight reddening, after 8 days no signs of irritation were reported. The initial slight signs of irritation were comparable with the effects of the control. The test article was considered to be not irritating to the rabbit eyes.
In a supporting non-GLP study according to a method comparable to OECD guideline 405, 50 mg the test substance was applied undiluted into the right eye of two rabbits (BASF, 1976). The left eyes were treated with talcum powder and served as control. One hour after application, slight reddening and secretion were reported. These effects were reversible within 24 hours. The eyes were also dyed dark red by the substance. The control eyes showed redness of the conjunctivae and slight edema, the redness was still present at the 24 hour time point and completely resolved after 8 days. The substance was considered to be not irritating to the rabbit eye.
Further toxicological data of category members:
Reliable data from several studies on irritation are available for the test article and for other members of the "perylene based pigments" category (see attached category justification). All of these data are taken into account for the evaluation and assessment of the irritation potential of the test article. Studies concerning the irritating potential for skin and eyes are available for all category members. In no study evidence for irritating or corrosive effects of the substances was observed. The category members can therefore all considered as not irritating to the skin and eyes.
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. Studies for skin and eye irritation are available. In both studies, no signs of irritation were observed. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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