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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-106-9 | CAS number: 5280-78-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Non skin sensitizing (OECD 429, 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:
- 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:
- - Substance type: red solid
- Physical state: solid
- Analytical purity: 99.6%
- Purity test date: 1.12.2006
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- dimethylformamide
- Concentration:
- 2.5, 5, and 10%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
a pretest was performed in two mice on three consecutive days.
- Compound solubility: The data showed that the highest test item concentration, which could be technically used was a 10% solution. Higher concentrations could not be achieved with other vehicles (e.g. acetone:olive oil, methyl ethyl ketone, propylene glycol, DMSO, or ethanol:water).
- Irritation: Irritation of the ear skin could not be observed, due to the colour of the test item.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: 3fold increase of S.I.
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal
surface of each ear lobe (left and right) with different test item concentrations of 2.5, 5, and 10% (w/v) in dimethylformamide. The application volume, 25 µl, was spread over the entire dorsal surface ( 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- EC3 = 6.7%
- Parameter:
- SI
- Remarks on result:
- other: 1.53, 1.43, and 2.37
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control: 5703 2.5%: 8735 5%: 8128 10%: 13466
- 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. Due to the colour of the test item iritation of the ear skin could bot be observed at the mid and high dose.
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, 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 144 was tested in two Local Lymph Node assays according to GLP (RCC 2007, Synthesia 2009). The study by RCC followed OECD testing guideline 429 without deviations. The study by Synthesia was performed with the non-radioactive version which uses lymph node cell count as the indicator. Animals exposed to test substance showed no pathological skin reactions and no other negative clinical symptoms of intoxication throughout the experiment. There was no significant difference in body weight increment of all groups in comparison to the vehicle control. There were no clinical observations attributable to the treatment with test substance. The test substance showed a tendency to increase ear weight at the highest dose level but not paired with lymph node hyperplasia. Residues of the test substance on the ears caused this increased weight.
The study at RCC resulted in simulation indeces of 1.53, 1.43, and 2.37 at concentrations of 2.5, 5, and 10% in dimethylformamide. A pre-test showed that DMF was the best suited solvent and that higher concentrations could not be achieved. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Due to the colour of the test item iritation of the ear skin could both be observed at the mid and high dose. The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. Pigment Red 144 is therefore non sensitizing on skin.
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..
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)