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EC number: 701-428-7 | CAS number: -
- 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 commercial form of the green pigment was tested for skin and eye irritation in rabbits prior to the introduction of GLP and OECD testing guidelines (BASF 1978). The studies were performed according the procedures published in the US Federal Register Vol. 38. The procedure for eye irritation is identical to the later adopted OECD guideline 405, whereas the procedure for skin irritation uses a more stringent 24h occlusive exposure with short observation period of 72h.
In the study for skin irritation, green staining of the skin interfered with erythema staining after 24h and also in some animals after 72h. No erythema were observed in animals for which scoring was possible. No edema was observed at either time point in any animal. After 7 days, the hypoderm and muscle under the treated sites were examined and no adverse findings were observed.
Considering the clear absence of effects, the skin irritation study is suitable to allow the conclusion "not classified" according to GHS criteria.
No findings on rabbit eyes were observed for any parameter (iris, conjuctivae, cornea) at any time point in any animal.
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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register 38 No 187 § 1500.41
- Version / remarks:
- 24h occlusive exposure, investigation of hypoderm and underlying muscles
- GLP compliance:
- no
- Specific details on test material used for the study:
- Heliogengrün 9140
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3-4kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least three days
ENVIRONMENTAL CON DITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 34 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact and scarified sites were tested on the same animal
- Vehicle:
- other: 50% Lutrol 400 (= PEG 400) in water
- Remarks:
- for moistioning
- Controls:
- other: yes, untreated skin sites
- Amount / concentration applied:
- 0.5g per site (1g per animal)
- Duration of treatment / exposure:
- 24h
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6.25cm2
- Type of wrap if used: PVC foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm vehicle
- Time after start of exposure:24h
OBSERVATION TIME POINTS
24h and 72h for skin findings, 7 days for hypoderm and muscle
SCORING SYSTEM: Draize - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, since no findings
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, since there were no findings
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- The green test material had stained the skin.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, since no findings
- Remarks on result:
- other: For half of the animals, green staining of the skin interfered with scoring.
- Irritant / corrosive response data:
- At the end of treatment (24h reading), scoring for erythema was not possible as the green test item had stained the skin.
At the 72h reading, scoring was still not possible for 3 animals. For the other 3 animals, no erythema (score = 0) was observed. Findings were equal for intact and scarified skin.
Edema was not observed in any animal at any time point (Score = 0). - Other effects:
- There were no adverse findings on the hypoderm and muscles underlying the treated skin sites.
- Interpretation of results:
- GHS criteria not met
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: US FEDERAL REGISTER 38 NO. 187, Paragraph 1500.42 page 27019 of 27. SEPT. 1973
- GLP compliance:
- no
- Specific details on test material used for the study:
- Heliogengrün 9140
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3 - 4 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 45 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing after application
SCORING SYSTEM: Draize
Time points investigated: 1h, 24h, 72h, and longer if needed
TOOL USED TO ASSESS SCORE: not specified - Irritation parameter:
- cornea opacity score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, since no findings
- Irritation parameter:
- iris score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no adverse findings
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, since no adverse findings
- Irritation parameter:
- chemosis score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no adverse findings
- Irritant / corrosive response data:
- One hour after the application, two rabbits showed slight wetness of the treated eyes.
- 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
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. Well reported in-vivo studies are available for skin and eye irritation. In both studies, the scores for the test item treated sites / eyes were clearly below the thresholds for classification as an irritant.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 tenth time in Regulation (EU) No 2017/776.
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