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EC number: 239-763-1 | CAS number: 15680-42-9
- 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 substance is not irritating to the skin and eyes of rabbits as tested in studies performed to protocols equivalent to OECD testing guidelines OECD 405 and 404.
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
- Study period:
- 1978
- 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: US FDA - Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959)
- Version / remarks:
- 24h occlusive application
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Weight: 1,5 - 2 kg
- Housing: housed individually
- Diet : standard diet of Nafag ad libitum
- Water (e.g. ad libitum):drinking water were given "ad libitum"
- acclimatization period: 4 days
Temperature: 22 + 1 °C
Humidity: 55%
Light: 10h/day
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24h, occlusive
- Observation period:
- 72h
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Approximately 24 hours before treatment an area of about 100 cm2/g body weight was shaved on the back of the rats by means of an electric clipper. The substance was applied by evenly dispersing it on the skin with a syringe and covered with occlusive dressing, which was held around the trunk with an adhesive elastic bandage. After 24 hours the dressings were taken off carefully and the reactions of the skin were appraised upon removal during an observation period of 8 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959).
During this observation period symptoms and mortality were also recorded.
The Draize system for scoring was applied to evaluate erythema and edema. - Irritation parameter:
- erythema score
- Basis:
- other: animals 1-5 (intact skin)
- Time point:
- other: 24, 48 and 72h, 4 and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- intact skin
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- other: animals 1-6 (intact skin)
- Time point:
- other: 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
Reference
Table 1: Drazie scores of treated skin at the 24 and 72h readings
animal no | 24h | 24h | 48h | 48 | |||||
intact skin | scarified skin | intact skin | scarified skin | ||||||
1 | male | Erythema | 0 | 0 | 0 | 0 | |||
Edema | 0 | 0 | 0 | 0 | |||||
2 | male | Erythema | 0 | 0 | 0 | 0 | |||
Edema | 0 | 0 | 0 | 0 | |||||
3 | male | Erythema | 0 | 1 | 0 | 1 | |||
Edema | 0 | 1 | 0 | 1 | |||||
4 | female | Erythema | 0 | 0 | 0 | 0 | |||
Edema | 0 | 0 | 0 | 0 | |||||
5 | female | Erythema | 0 | 0 | 0 | 0 | |||
Edema | 0 | 0 | 0 | 0 | |||||
6 | female | Erythema | 1 | 1 | 0 | 3 | |||
Edema | 0 | 0 | 0 | 0 |
At the time points of 72h, 4 days and 7 days, all scores were 0.
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:
- 1978
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- In three of six animals, eyes were rinsed with physiological saline 30 seconds after treatment., 7 day observation period
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation:
- Weight at study initiation: 1.5 - 2 kg
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least four days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 1 °C
- Humidity (%): 55 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- single treatment. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
- Observation period (in vivo):
- The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 6 rabbits
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3,4,5,6
- Time point:
- other: days 1,2,3,4,7
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2,3,4,5,6
- Time point:
- other: days 1,2,3,4,7
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1,2,3,4,5,6
- Time point:
- other: days 1,2,3,4,7
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2,3,4,5,6
- Time point:
- other: days 1,2,3,4,7
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The pigment has been tested for skin and eye irritiaton in rabbits in 1978.
For the eye irritation studies, the procedures differ from the OECD guideline in a shorter observation period of 7 days. Considering that all scores were zero at all time points, it is not expected that a longer observation period would have revealed a hazard.
For the skin irritation studies, the procedures are more stringent than the OECD guideline 404 since the exposure lasts 24h. For half of the animals, the skin was scarified. The observation period is shorter and only readings at 24h and 72h are reported. Since all scores at 72h were 0 and individual scores were not higher than 1, it is acceptable to have the shorter observation period.
The test materials tested were not characterised for the presence of particles in the nano-size range. However, since no organic pigment was ever identified as a skin or eye irritant, the lack of the characterization of the particle properties is not relevant for the assessment of irritation.
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. 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 thirteenth time in Regulation (EC) No. 2018/1480.
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