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Diss Factsheets
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EC number: 225-555-8 | CAS number: 4926-55-0
- 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
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Endpoint summary
Administrative data
Description of key information
According to the weight of evidence approach with available studies (Reed, 1984, Klimisch 2, Human Repeated Insult Patch Test ; Burnett, 1979, Klimisch 4, GPMT ; Chapdelaine, 2000, Klimisch 2 LLNA ) performed in order to assess the potential sensitising effect of the test substance. No adverse effect including sensitising effect was observed during the two studies on volunteersn on guinea pigs or mice. Hence, the registered substance HC Yellow No 2 was not classified.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Two studies were available to assess the potential sensitising effect of the test substance : Two Human Repeated Insult Patch Tests were performed (Reed, 1984, Klimisch 2)
The entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 9 consecutive applications of the test material. The patches were removed 24 hours after application and evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to sites on the opposite arm previously unexposed to the test material. Patches were removed after 24 hours. The sites were grades 24 and 48 hours after removal.
- None of the 104 subjects used in the first study developed sensitization due to treatment with the 3% test item
- None of the 116 subjects used in the second study developed sensitization due to treatment with the 3% test item
A Guinea Pigs Maximisation Test was performed (Burnett, 1979, Klimisch 4) :
10 female Guinea pigs were used in this study. On the first day of experiment, three pairs of intradermal injections were performed on each test animal containing 0.1% solution of the test substance, Freunds complete adjuvant. The second induction was performed with topical application of the test item (25% in petrolatum) under occlusive patch for 48 hours. Two weeks later, the animals were challenged with another topical application of the compound under occlusive patch for 24 hours using 3% test item concentration. Observation was performed 24, 48 and 72 hours after removal of the occlusive bandage. Under the experimental conditions of the study, the test substance HC Yellow No. 2 did not induced primary irritation to Guinea Pigs skin after challenge.
A LLNA was performed (Chapdelaine, 2000, Klimisch 2, equivalent to OECD Guideline 429) :
25 μL test preparation applied to dorsal aspect of ear lobe of CBA/Ca mice daily for 3 days. 5 days after the first application, 250 μL of a solution containing 20 μCi/mL 3H-thymidine was injected intravenously. 5 hours later the animals were euthanized and the draining auricular lymph nodes were removed. The compound is not positive (>3) at any concentration and it is not sensitizer in this test. Under the experimental conditions of this study, the test item HC Yellow No. 2 did not induced delayed contact hypersensitivity to mice after skin.
Taken together, the four available studies showed no sensitisation effect on human, guinea pigs and mice. According to the weight of evidence approach, and the negative results at the different available studyes, the registered substance was not classififed for skin irritation.
Justification for classification or non-classification
Taken together, the four available studies showed no sensitisation effect on human, guinea pigs and mice. Based the weight of evidence approach, and the negative results at the different available studyes, the registered substance was not classififed for skin irritation accordingto CLP regulation.
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.
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