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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
Pigment Red 48:2(Ca) was found to be non sensitizing in a valid local lymph node assay in mice (Clariant 2007). The study followed OECD testing guideline 429 (2002) and the principles of GLP, and the choice of doses is adequately justified.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- - Aggregate state at room temperature: Solid
- Colour: Red
- Storage: At room temperature
- Expiration Date: April 04, 2010
- Manufacturing Date: March 21, 2003
- Identity: Graphtol-Rot P2B VP 2747
- Purity: 84.8% (of Pigment Red 48:2)
- Batch No.: Vers. EB 98-04 or Kron 393014
- Certificate of Analysis: AZ 212/e2 - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
- Housing: single Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
- Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
- Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
- Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
- Environment: temperature 22 + 3°C
- Relative humidity 30 - 70%
- Artificial light 6.00 a.m. - 6.00 p.m.
- Age: 7 - 8 weeks (beginning of acclimatisation)
- Housing: The animals were distributed into the test groups at random and identified by cage number.
- Acclimisation: under test conditions after health examination. Only animals without any visible signs of illness were used for the study. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 6.25, 12.5, and 25 %. Concentrations were in terms of material as supplied.
- No. of animals per dose:
- 4 females (nulliparous and non-pregnant)
- Details on study design:
- The test item was placed into a volumetric flask glass beaker on a tared balance and the vehicle (acetone: olive oil (4+1)) was quantitatively added. The test item concentrations were prepared individually. Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer. The preparations were made freshly before each dosing occasion. The data of the non GLP study 1010111 performed with the same test item showed that the highest test item concentration, which could be technically used was a 25 % suspension. Even warming and sonicating could not achieve a higher concentration. With other vehicles, e.g. DMF, DMSO, ethanol: deionised water (7+3) or propylene glycol, higher concentrations could also not be achieved. Due to the colour of the test item no irritation effects were observable at the concentration of 25 %. The test item in the main study was, therefore, assayed at 6.25, 12.5, and 25 %. Concentrations were in terms of material as supplied.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not required
- Positive control results:
- The validation- / positive control study was performed with alpha- Hexylcinnamaldehyde in acetone:olive oil (4+1) using CBA/CaOlaHsd mice in December 2006.
- Key result
- Parameter:
- SI
- Value:
- 1.05
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 12.5%
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 6.25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 700.01
- Test group / Remarks:
- 25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 10 840.9
- Test group / Remarks:
- 12.5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 9 978.42
- Test group / Remarks:
- 6.25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 315.07
- Test group / Remarks:
- Control group
- Interpretation of results:
- GHS criteria not met
Reference
All treated animals survived the scheduled study period and no systemic toxicity was observed. Due to the colour of the test item local irritation reactions such as ear redness could not be detected.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For the endpoint of skin sensitization, one study is available for Pigment Red 48:2(CA) (Clariant 2007). It was performed with a commercial product of adequately high content of Pigment Red 48:2 with doses of 6.25, 12.5, and 25 % in acetone/olive oil. Higher concentrations could not be achieved due to insolubility in this and other vehicles. Irritating properties could not be scored due to the staining properties of the red pigment. This did not affect the outcome, as there was no increase in stimulation index.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 skin sensitization according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
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