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Diss Factsheets
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EC number: 203-404-7 | CAS number: 106-50-3
- 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
Key value for chemical safety assessment
Effects on fertility
Additional information
A one-generation reproduction toxicity study has been performed in the male Sprague Dawley rat. 0.5 mL of hair dyes, one corresponding to a semi-permanent and the other to an oxidative dye, both containing 2.2% PPD (approximately 11 mg/kg/day) was applied topically to the backs of 25 rats twice a week for 10 weeks. No evidence of reduced fertility was observed (Burnett et al., 1981; see IUCLID section 7.8.1 – Toxicity to reproduction for additional study details). A dermal two-generation reproduction toxicity study has been performed in Sprague Dawley rats with hair dye formulations containing 2%, 3% or 4% PPD were mixed with an equal volume of hydrogen peroxide. No compound-related effects on survival, general appearance, food consumption, body weight gain, fertility of males or females or on gestation, lactation or weaning indices were observed (Burnett and Goldenthal, 1988; see IUCLID section 7.8.1 – Toxicity to reproduction for additional study details). In addition, no adverse effects on reproductive organs or tissues were observed in a 90-day repeated dose oral gavage study (The key study for evaluation of repeated dose toxicity – see IUCLID section 7.5.1 – Repeat dose toxicity: oral). In summary, the studies described above support the proposal to eliminate the necessity of further animal testing and support waiving the need for a two generation reproductive toxicity test.
Short description of key information:
Data waiver provided for 2-generation reproductive toxicity study based on no reproductive effects observed in a dermal 1-generation rat study (oxidative hair dye containing 2.2% PPD) or a dermal 2-generation rat study (hair dye containing 2, 3, or 4% PPD). Details are provided in IUCLID5.
Effects on developmental toxicity
Description of key information
Oral: developmental gavage study in rats (OECD 414) - developmental effects were observed at maternally toxic levels.
Maternal NOEL = 5 mg/kg
Developmental NOEL = 10 mg/kg
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
Additional information
Pregnant female rats were exposed to the test substance via gavage on day 6-19 of gestation at concentrations of 5, 10, and 20 mg/kg. Maternal toxicity was observed at ≥10 mg/kg/day, as evidenced by a transiently lower mean body weight gain. Although not statistically significant, slightly lower gravid uterus weights and mean foetal weights (accompanied by a slightly retarded ossification) were observed at 20 mg/kg. The maternal NOEL was 5 mg/kg/day and the developmental NOEL was 10 mg/kg/day. The test substance was not embrotoxic, fetotoxic, or teratogenic.
Justification for classification or non-classification
The test substance did not adversely affect reproductive organs and was not uniquely toxic to the developing foetus. The substance does not need to be classified for reproductive toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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