Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-303-5 | CAS number: 7023-61-2
- 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 48:2 and of other members of the same category indicate that Pigment Red 48:2 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:
- 1977
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Body weights not recorded.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - 95% C. I. Pigment Red 48 - Calcium Salt
- 5% modified wood rosin derivative
- A red powder labelled PD 1201 EG 9146 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were caged singly and kept in a room maintained at a temperature of 21°C (+2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.
Animals: Healthy Sprague-Dawley derived rats, bred on the premises, aged 6 - 7 weeks, having an average body weight of 176 g (males)
and 142 g ( females ) - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 50% aqueous solution
- Details on oral exposure:
- Rats had been fasted for 18 h prior to dosing at a rate of 20 mL/kg.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: no adverse findings
- Gross pathology:
- no adverse findings
- Other findings:
- In all animals the faeces were stained red for approximately 48 hours.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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
- 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:
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- BASF test
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C.I. Pigment Red 48:2 / Litholscharlach 4440
- Substance type: Mono azo dye
- Physical state: solid
- Other: Ca-salt with "Harzseife" (resinate) - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder, SPF, Wiga
- Mean weight at study initiation: males: 134 g; females: 118 g
ENVIRONMENTAL CONDITIONS: not reported - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal, p.c., 50 cm2
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g
- Concentration (if solution): 50 % aqueous suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No weighing was performed. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes - Statistics:
- LD 50 was estimated approximately
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No abnormalities detected
- Gross pathology:
- No abnormalities detected
- Other findings:
- Red substance residues, redness not detectable.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Additional information
Commercial products of Pigment Red 48:2 differ in their content of additives that are added depending on the intended application. Typical additives are resin, surfactants, inorganic fillers and dye-stuff. The content or identity of the additives is not documented in all studies as these were performed prior to the introduction of GLP. As no adverse effects were noted and very high doses tested, the influence of additives on acute toxicity is considered to be negligible.
Acute oral toxicity
The key study for acute oral toxicity (Drake 1977) was performed in rats with sample of adequately high pigment content. The procedure is comparable to OECD test guideline 423 (2001) with the exception that the body weight was not recorded at the end of the observation period. All rats survived a single application of 5000 mg/kg bw test substance by gavage without showing clinical signs of toxicity. No adverse findings were noted upon necropsy. Rats excreted red feces during the first two days which is caused by the staining properties of the red pigment. The key study is representative for all available study reports on acute oral toxicity.
Data on the sulfonated amine moiety of Pigment Red 48:1 is also available (4-amino-6-chlorotoluene-3-sulphonic acid; CAS 88-51-7). This moiety is not acutely toxic via the oral route (LD50 >7500 mg/kg bw).
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 48:2 by the absence of a chlorine on the sulfonated amine moiety. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Ca2+. 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. Overall, Pigment Red 48:2 is considered to be of low acute toxicity.
Data on the sulfonated amine moiety of Pigment Red 48:1 is also available (4-amino-6-chlorotoluene-3-sulphonic acid; CAS 88-51-7).This moiety is not acutely toxic via the inhalation route (LC50 >13.0 mg/L).
Acute dermal toxicity
The key study for acute dermal toxicity (BASF 1974) was performed in rats with a commercial product following a protocol which is comparable to OECD testing guideline 402 (1987). It was performed prior to the introduction of GLP but is documented adequately. The commercial product contained an unknown amount of resin which is acceptable as a dose of 2500 mg/kg bw was applied. No indication of adverse findings was observed.
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.