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EC number: 277-552-6 | CAS number: 73612-29-0
- 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
Pigment Red 57-Sr is not irritating to skin and eyes as determined in GLP and OECD testing guideline compliant studies in rabbits (BASF 1992).
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Erythema score not assessable due to red staining of the test substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Physical state: powwder, red
- Analytical purity: the test substance has not been fully characterized analytically.
- Lot/batch No.: CS-485
- Stability under test conditions: has not been determined analytically.
- Storage condition of test material: room temperature
- Name of test material (as cited in study report): LITHOL RUBIN D 4569-SR-LACK - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 2.7 kg, females: 2.4 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance has been moistened with aqua bidest; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: upper third ofthe back or flanks, test patch 2.5 CM X 2.5 CM
- Type of wrap if used: test patches were secured in positino with a porous dressing (four layers of absorbent gauze + porous bandage).
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure with lutrol and lutrol/water (1:1)
READINGS: 30 - 60 minutes after removal of the test patches and 24h, 48 h, 72 h, 8d after the beginning of application - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- other: no effects observable
- Remarks on result:
- other: not determineable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Interpretation of results:
- GHS criteria not met
Reference
Erythema score could not be read because of staining due to the colour of the test substance up to the 72 h reading. Day 8 reading no erythema were seen (score 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- eyes were not washed out
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Physical state: powder, red
- Analytical purity: the test substance has not been fully analytically characterized
- Lot/batch No.: CS-485
- Stability under test conditions: the stability has not been determined analytically
- Storage condition of test material: room temperature - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 3.6 kg, females: 3.8 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume ( (about 58 mg of the comminuted test substance)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out
READINGS: 1h, 24h, 48h, 72h after application - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1 and # 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Discharge after one hour
- Interpretation of results:
- GHS criteria not met
Reference
Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out |
||||||
Animal |
Reading |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|
|
|
Opacity |
|
Redness |
Chemosis |
|
1 |
1 h |
0 |
0 |
1 |
0 |
- |
2 |
1 h |
0 |
0 |
1 |
0 |
- |
3 |
1 h |
0 |
0 |
1 |
0 |
- |
1 |
24 h |
0 |
0 |
0 |
0 |
- |
2 |
24 h |
0 |
0 |
2 |
0 |
- |
3 |
24 h |
0 |
0 |
0 |
0 |
- |
1 |
48 h |
0 |
0 |
0 |
0 |
- |
2 |
48 h |
0 |
0 |
1 |
0 |
- |
3 |
48 h |
0 |
0 |
0 |
0 |
- |
1 |
72 h |
0 |
0 |
0 |
0 |
- |
2 |
72 h |
0 |
0 |
0 |
0 |
- |
3 |
72 h |
0 |
0 |
0 |
0 |
- |
mean animal 1 |
24 - 72 h |
0.00 |
0.00 |
0.00 |
0.00 |
|
mean animal 2 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.00 |
|
mean animal 3 |
24 - 72 h |
0.00 |
0.00 |
0.00 |
0.00 |
|
mean total |
24 - 72 h |
0.00 |
0.00 |
0.33 |
0.00 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Pigment Red 57-Sr was investigated for skin and eye irritation in rabbits (BASF 1992). Both studies were performed following the principles of GLP and according to OECD testing guidelines (no. 404 and 405). A sample of commercial quality was tested. No indication of skin irritation was observed, with the limitation that the erythema score could not be read because of staining due to the colour of the test substance up to the 72 h reading. At the reading on day 8 no erythema were seen. Application to the eyes of three animals caused transient mild reddening of the conjunctivae of one animal.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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