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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
According to the results of the two keys studies (Dose Range Finding and Definitive Teratology Study York, 2005, OECD 414, GLP compliant), the No Observe Adverse Effect Level NOAEL for materno- and embryo-toxicity of the test item HC Yellow No. 2 in Developmental toxicity test was defined at 500 mg/kg/day. Hence the test substance was not classified for teratogenicity.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Two key studies were availables in order to assess the potential teratogenicity effect of the test item : A first Dose Range Finding Study was performed (York, 2005, Klimisch 2, OECD 414 equivalent, GLP compliant) :
Forty presumed pregnant Crl:CD(SD) rats were randomly assigned to five dosage groups, eight rats per group. Solutions of the test substance or the vehicle, PEG 400, were administered orally (gavage) once daily to these naturally bred female rats on days 6 through 20 of presumed gestation (GD 6 - 20) at dosages of 0, 25, 75, 200 and 500 mg/kg bw/d. Viabilities, clinical observations, body weights and feed consumption values were recorded. All surviving rats were sacrificed on GD 21. The gravid uterus was excised, weighed and subsequently examined for the number and distribution of corpora lutea,
implantation sites and uterine contents. A gross necropsy was performed. Foetuses were weighed and examined for gross external alterations and sex.There were no test substance related effects on body weights, body weight gains, gravid uterine weights, corrected maternal body weights or corrected maternal body weight gains or absolute or relative feed consumption values. No Caesarean-sectioning or litter parameters were affected by dosages of the test substance as high as 500 mg/kg/day. All fetuses appeared normal at gross external examination.
Based on these data, dosages of 0 (Vehicle), 50, 200 and 500 mg/kg/day of the test item were selected for the developmental toxicity study in rats (York, 2005, Klimisch 1, OECD 414, GLP compliant). One hundred presumed pregnant Crl:CD (SD) rats (25 per group) were randomly assigned to four dosage groups. Solutions of the test substance or the vehicle, 100 % polyethylene glycol 400 (PEG 400), were administered orally once daily to rats on days 6 -20 of gestation (GD 6 - 20) at dosages of 0, 50, 200 and 500 mg/kg bw/d. Viabilities, clinical observations, body weights and feed consumption values were recorded. All surviving rats were sacrificed on GD 21. The gravid uterus was excised, weighed and subsequently examined for the number and distribution of corpora lutea, implantation sites and uterine contents. A gross necropsy was performed. Foetuses were weighed and examined for gross external, soft tissue and skeletal alterations and sex.
One 200 and two 500 mg/kg bw/d dosage group rats were found dead on GD 17, 19 or 20. These deaths were considered related to aspiration of the test substance. Significantly increased incidences of yellow and/or orange urine and discoloration and yellow perioral substance occurred in the 50, 200 and 500 mg/kg bw/d dosage groups. Discoloration of internal organs was also observed. All of these colour changes were not considered to be adverse. The 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.
On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse.
Justification for classification or non-classification
According to the results of the two keys studies (Dose Range Finding and Definitive Teratology Study (York, 2005, OECD 414, GLP compliant),the No Observe Adverse Effect Level NOAEL for materno- and embryo-toxicity of the test item HC Yellow No. 2 in Developmental toxicity test was defined at 500 mg/kg/day. Hence the test substance was not classified for teratogenicity.
Additional information
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.
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