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EC number: 220-701-7 | CAS number: 2871-01-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
On the basis of these data from the key studies, the maternal no- observable-adverse-effect-level (NOAEL) for HC Red No. 3 was 200 mg/kg/day and the developmental NOAEL was 1000 mg/kg/day. The test substance was not classified for Teratogenicity according to the CLP criteria.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two key studies were available to assess the potential teratogenic effect of the HC Red No.3 :
-A first Dose Range Finding study was performed in order to select appropriate dose for a Definitive Teratogenicity test (York, 2005, Klimisch 2, OECD 414, GLP compliant). Forty presumed pregnant Crl:CD rats, eight per group, were randomly assigned to five dosage groups. Formulations of the test substance, HC Red 3, and/or the vehicle, 100% polyethylene glycol 400 (PEG 400), were administered orally once daily to rats on days 6 through 20 of gestation (DGs 6 through 20) at dosages of 0, 50, 200, 500 and 1000 mg/kg/day. The dosage volume was 5 mL/kg. Viabilities, clinical observations, body weights and feed consumption values were recorded. All rats were sacrificed on DG 21. The gravid uterus was weighed and examined for the number and distribution of corpora lutea, implantation sites and uterine contents. Fetuses were weighed and examined for gross external alterations and sex. Caesarean-sectioning and subsequent fetal observations were conducted without knowledge of dosage group. the Test Article HC Red No. 3 induced no significant differences in body weight between treated and control animals. No significant differences the litter sizes were observed between treated and control animals. No significant differences in the number of live or resorbed foetuses were observed between treated and control animals. No differences in foetal abnormalities were observed between treated and control groups. The NOAEL for materno and embryo-toxicity was considered to be 1000 mg/kg/day.
- Based on the results of the previous Dose Range Finding study, the selected doses for the main study were 0, 50, 200 and 1000 mg/kg bw/d (York, 2005, Klimisch 1, OECD 414, GLP compliant). Solutions of the test substance HC Red 3 and/or the vehicle, 100% polyethylene glycol 400 (PEG 400), were administered orally once daily to rats (6 rats per dose group) on days 6 through 20 of gestation (DGs 6 through 20). The dosage volume was 5 mL/kg. Viabilities, clinical observations, body weights and feed consumption values were recorded. All surviving rats were sacrificed on DG 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. Fetuses were weighed and examined for gross external alterations, sex and either soft tissue or skeletal alterations. The treatment by oral gavage of the test article HC Red No.3 induced Significant increases in the incidences of discolored skin, fur and/or urine, as well as perioral substance in rats assigned to the 50 mg/kg/day and higher dosage levels and were considered to be related to the color of the test substance. The 1000 mg/kg/day dosage produced additional increased clinical signs of perivaginal substance, as well as decreases in body weight gains, corrected maternal body weights and body weight gains and feed consumption values. The 1000 mg/kg/day dosage caused reversible delays in ossification (reductions in the numbers of ossified hindlimb metatarsals and phalanges). On the basis of these data, the maternal no- observable-adverse-effect-level (NOAEL) for HC Red No. 3 was 200 mg/kg/day and the developmental NOAEL was 1000 mg/kg/day.
Justification for classification or non-classification
On the basis of these data from the key studies, the maternal no- observable-adverse-effect-level (NOAEL) for HC Red No. 3 was 200 mg/kg/day and the developmental NOAEL was 1000 mg/kg/day. The test substance was not classified for Teratogenicity according to the CLP criteria.
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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