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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
Studies of Pigment Red 57 -Sr and of other members of the same category indicate that Pigment Red 57 -Sr is not acutely toxic via the oral, inhalation, and dermal route of exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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, Substance number 91/3 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR . K . THOMAE GMBH, 7950 BIBERACH, BRD
- Age at study initiation: YOUNG ADULT ANIMALS
- Mean weight at study initiation: 150 - 300 g +- 20%
- Fasting period before study: AT LEAST 16 HOURS, WATER WAS AVAILABLE AD LIBITUM .
- Housing: SINGLE HOUSING.
- Diet (e.g. ad libitum): KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG 4303 KAISERAUGST, SWITZERLAND , AD LIBITUM .
- Water (e.g. ad libitum): TAP WATER AD LIBITUM PER DAY
- Acclimation period: AT LEAST 1 WEEK
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 H/12 H - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous tylose solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 22 g/100 mL, 0 .5% solution of Tylose CB 30.000 in Aqua Bidest.
- Justification for choice of vehicle: Aqueous formulation corresnponds to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 2200 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Frequency of observations for signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once ach workday for the individual animals.
- Frequency of general observations and mortality: check was made twice each workday and once on mortality: Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.
- Frequency of weighing: individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: Yes, necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before euthanisation with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 mg/kg bw
- Mortality:
- No mortality observed
- Clinical signs:
- other: No abnormalities observed
- Gross pathology:
- No pathologic findings noted
- Other findings:
- Skin coloured red, discoloured feces (red) at day 1, noted in all animals
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 200 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the category read-across justification in the category object.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 518 mg/m³ air
- Based on:
- other: read-across
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.76 mg/L air
- Based on:
- other: read-across
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 518 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the category read-across justification in the category object.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- other: read-across
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Additional information
Acute oral toxicity
Pigment Red 57-Sr caused no toxicity in rats in two GLP and OECD guideline compliant studies at a limit dose of 2200 and 2000 mg/kg bw (Miyata 2005 and BASF 1992, respectively).
Acute inhalation toxicity
The hazard of acute inhalation toxicity is derived from experimental data on analogue pigments present in the category. A valid study is available for Pigment Red 57:1 which differs from Pigment Red 57(Sr) by the presence Ca2 + instead of Sr2 +. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Sr2+ and contains a chloride on the sulfonated amine moiety. Acute inhalation exposure to aerosol of Pigment Red 48:1 at a concentration of 4.76 mg/L caused mortality in one of ten rats (Capelle 1993) as assessed in a GLP compliant study following OECD testing guideline 403. The study with Pigment Red 57:1 (Sachsse 1976) was performed in rats with a commercial product following a protocol which is comparable to OECD testing guideline 403 (1981). A limit test was performed with the highest concentration of dust that was technically achievable (1518 ± 176 mg/m3 air). No mortality, no clinical signs and no findings upon necropsy were observed.
Acute dermal toxicity
The hazard of acute dermal toxicity is derived from experimental data on analogue pigments (48:1, 48:2, 48:3, and 57:1) present in the category. For these pigments, the LD50s all exceeded 2500 mg/kg bw. As a result, it can be concluded that Pigment Red 57-Sr is also not acutely toxic via the dermal route.
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 acute oral, dermal or inhalation toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
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