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EC number: 255-005-2 | CAS number: 40618-31-3
- 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
Non skin sensitizing (LLNA, GLP).
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:
- 2005
- 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:
- - Substance type: red solid
- Physical state: solid
- Analytical purity: 99.91%
- Purity test date: 20 August 2004
- Lot/batch No.: W02002
- Expiration date of the lot/batch: August 20, 2009
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Stability in solvent: > 24 hrs in DMSO at room temperature - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.3 g
- Housing: single caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 2004-08-27 To: 2004-11-16 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, and 15 % (w/v).
- No. of animals per dose:
- 4
- Details on study design:
- To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 2.5, 5, 10, and 15 % (w/v) (pretest excluded from Statement of Compliance). The data showed that the highest test item concentration, which could be technically used, was a 15 % suspension in acetone:olive oil, 4:1 (w/v). Also in other vehicles tested (DMSO, DMF), a higher concentration could not be suspended.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not needed.
- Positive control results:
- performed in October 2004 (RCC-CCR Study No. 860600) EC3 = 9.9%
- Parameter:
- SI
- Remarks on result:
- other: 0.9, 0.9, and 1.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 3855.2 (control) 3352.4 (5%) 3507.5 (10%) 4999.2 (15%)
- Interpretation of results:
- GHS criteria not met
Reference
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed.
The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Pigment Red 214 was tested in a Local Lymph Node assays according to GLP and OECD testing guideline 429 (RCC 2005). Concentrations of 5, 10, and 15 % (w/v) in acetone/olive oil (4:1) were applied. Higher concentrations were technically not feasible as shown in a pre-test. Simulation indices were 0.9, 0.9, and 1.3 proving absence of a skin senstising potential. No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Reddening of the ears could not be determined since the ears were dyed red by the test item. However, no other signs of local irritation such as swelling of the ears could be observed. The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
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 under Regulation (EC) No. 1272/2008.
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