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EC number: 231-494-8 | CAS number: 7585-41-3
- 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 pigment 48:1(Ba) is not irritating to eyes and skin of rabbit (BASF 1974 and Ciba 1973).
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:
- Documentation insufficient for assessment of erytheme score, test item colours the skin.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. Exposure of 1, 5 and 15 minutes was not done in this experiment
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C.I.Pigmentred 48:1, Monoazofarbstoff. / Litholscharlach 3700
- Physical state: solid
- Analytical purity: 100 % - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Gaukler (Breeder)
- Weight at study initiation: female: 2.89 kg, male: 2.97 kg - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution - Duration of treatment / exposure:
- 20 hours
- Observation period:
- 8 d
- Number of animals:
- 1 female, 1 male
- Details on study design:
- Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.
TEST SITE
- Area of exposure: dorsal
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: cotton lobe
SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Not scorable at 24h due to red staining by the test item
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h and 8 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Other effects:
- Red substance residues after 24 h. No abnormality and no red substance residues detected after 8 d.
- 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
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Partly limited documentation, only two animals used
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C.I.Pigmentred 48:1, Monoazofarbstoff.
- Physical state: solid
- Analytical purity: 100% - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler (Breeder)
- Weight at study initiation: 2.99 kg (female), 3.0 kg (male)
ENVIRONMENTAL CONDITIONS
not reported - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum (amorph) into the other eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µl (corresponds to 100 mg)
- Concentration: undiluted - Duration of treatment / exposure:
- Treatment was once. The eye was left unwashed, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1 female, 1 male
- Details on study design:
- SCORES
Descriptive scores of the raw data have been converted to Draize numerical scores
TOOL USED TO ASSESS SCORE: fluorescein - 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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Other effects:
- Red compound residues were observed after one hour
- 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
Skin irritation was investigated in two rabbit studies (BASF 1974 and Ciba 1973). During the key study, two rabbits were treated with a commercial product for up to 20h using occlusive conditions. No abnormalities were detected at the 1 and 8 day readings (BASF AG 1974), but red residues on the skin interfered with erythema scoring. Very mild erythema and absence of edema were observed at the 24 and 72h reading in a study following the standard procedure of the The Food and Drug Administration of the U.S.A. in The Federal Register (17 September, 1964 § 191.11) (Ciba 1973). This involves 24h occlusive application and represents a worse case than the 4h semi-occlusive application required by the OECD testing guideline for skin irritation. Overall, Pigment Red 48:1 is considered to be non irritating to skin.
Assessment of eye irritation was performed in two rabbit studies performed with commercial products according to a protocol similar to OECD testing guideline 405. The main difference is that there are limited details on non-irritation related parameters such as body weight. Slight and transient redness of conjunctivae and no findings on iris and cornea were observed (Ciba 1973, BASF 1974). It is concluded that Pigment Red 48:1 is not irritating to eyes.
Justification for classification or non-classification
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 irritation according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
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