Registration Dossier
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EC number: 266-564-7 | CAS number: 67075-37-0
- 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 test substance is considered as not irritating to the skin and eyes of rabbits.
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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W. Ostrop/Meerbusch
- Weight at study initiation: mean weight: 2.1 kg
- Housing: one per cage
- Diet (e.g. ad libitum): "muemmel z" (ssniff/Soest)
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 4-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 (relative humidity)
- Photoperiod (hrs dark / hrs light): according to the day light rhythm - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and damaged skin
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg compound slightly thickened with water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: double layer gauze covered by indifferent impermeable PVC (5x5 cm) foil and elastic bandage (ElastoflexR)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize numerical scores. - Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- other: scoring not possible due to the skin coloring by the substance
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: timepoint not evaluated
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- other: scoring not possible due to the skin coloring by the substance
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- other: 8 days
- Remarks on result:
- other: scoring not possible due to the skin coloring by the substance
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: timepoint not evaluated
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: time point not evaluated
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- The test article caused edema formation below the threshold of regulatory significance. In two animals, the edema was not fully reversed after 8 days but is expected to have cleared after 14 days. The erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results show that there is no corrosive potential of the substance. However, the substance can not be properly evaluated due to substance residues / coloring. The substance is regarded as slightly irritatin, however below the level of regulatory significance.
Reference
Overview of results:
Animal 1 | Animal 2 | Animal 3 | Animal 4 | Animal 5 | Animal 6 | ||
intact skin | |||||||
erythema | 24 h | * | * | * | * | * | * |
72 h | * | * | * | * | * | * | |
8 days | * | * | * | * | * | * | |
edema | 24 h | 3 | 3 | 1 | 2 | 3 | 2 |
72 h | 0 | 1 | 1 | 1 | 1 | 1 | |
8 days | 0 | 0 | 0 | 1 | 1 | 0 | |
damaged skin | |||||||
erythema | 24 h | * | * | * | * | * | * |
72 h | * | * | * | * | * | * | |
8 days | * | * | * | * | * | * | |
edema | 24 h | 2 | 2 | 0 | 2 | 3 | 2 |
72 h | 1 | 0 | 0 | 2 | 2 | 2 | |
8 days | 1 | 0 | 0 | 0 | 1 | 0 |
* could not be scored due to coloration of the skin from the substance
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: W. Ostrop, Meerbusch
- Weight at study initiation: mean weight: 2.1 kg
- Housing: one per cage
- Diet (e.g. ad libitum): "muemmel z" (ssniff/Soest)
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: 4 - 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 (relaive humidity)
- Photoperiod (hrs dark / hrs light): according to the day light rhythm - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL bulk volume - Duration of treatment / exposure:
- One single application. Lids have been gently hold together for 1 sec. The eye was left unwashed.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize numerical scores.
TOOL USED TO ASSESS SCORE: Ophtalmoscop; after 8 days with fluorescein and UV-light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- All scores at all time points were zero.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the test substance was investigated for its irritating potential. All scores were noted to be zero at all observation time points and thus, the test substance was concluded to be not irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
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.
Skin irritation
The test substance slightly thickened with water (500 mg) was applied to intact and damaged skin of six New Zealand White rabbits in a skin irritation study comparable to OECD guideline 404 (BASF, 1978). The test substance was applied on a tissue (2.5 x 2.5 cm) held in place by an occlusive dressing for 24 hours. The test rabbits were observed for 8 days. Application caused forming of edema (mean scores (24 and 72 hours) for intact and damaged skin were 1.6 and 1.5, respectively). Determination of erythema was not possible at 24 and 72 hours and at day 8 after treatment, due to substance induced coloration of the skin. Therefore, based on the result of this study, the test substance does not have high potential to cause skin irritation, however a definitive conclusion cannot be drawn.
In several studies performed with other category members the potential to cause skin irritation was found to be very low. None of these studies raised any concerns regarding irritation and therefore none of the substances require classification. All compounds were considered to be not irritating to skin.
Conclusion: Based on the available data for the test substance and taking the data of category members into account, no classification for skin irritation is warranted. The test substance is considered to be not irritating.
Eye irritation
In an eye irritation study comparable to guideline 405, 100 µl of the test article was applied unchanged into the conjunctival sac of the right eye of six New Zealand White rabbits (BASF AG, 1978). Eyes were not rinsed. The left eyes remained untreated and served as controls. Animals were observed 24, 48 and 72 hours and 8 days after the treatment and the irritation parameters were scored. The cornea, iris, conjuctivae and chemosis scores were 0 at all time points (24, 48 and 72 hours) for all animals. Therefore, based on the results of this study, the test article was considered to be not irritating to the eye.
In several studies performed with other category members the potential to cause eye irritation was found to be very low. None of these studies raised any concerns regarding irritation and therefore none of the substances require classification. All compounds were considered to be not irritating to the eye.
Conclusion: Based on the available data for the test substance and taking the data of category members into account, no classification for eye irritation is warranted. The test substance is considered to be not irritating.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for irritation is not warranted under Regulation (EC) No.1272/2008.
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