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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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed using oxidative hair dye containing 2, 3, or 4% test substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
- Principles of method if other than guideline:
- Samples were applied topically twice weekly throughout the growth, mating, gestation and lactation phases of the F0 parents to the weaning of the F1a and F2b litters. Fertility, gestation and foetal viability indices and body weights were evaluated for the six treatment groups and these were compared with the values for the three concurrent control groups. After the F2b litters had been weaned, five male and five female F1 parents were necropsied and tissues were taken for microscopic examination.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- - Purity: The dye used to prepare the formulations was obtained from commercial suppliers and was used without further purification. All materials were within the Clairol specifications for use in the manufacture of hair-colouring products.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: The test substance was mixed in a formulation with many other components in three different concentrations. The test formulations were then prepared fresh for each application by mixing equal volumes of the dye solution and 6% hydrogen peroxide.
- Details on mating procedure:
- F0 and F1 males and females were paired, care being taken to ensure that littermates were not paired. Mating continued for 15 days during which time the females were examined daily for the presence of a sperm plug in the vagina. The day on which sperm or the copulatory plug was found was termed day 0 of gestation. After weaning of the F1a and F2a litters, the rats were given a 10-day rest and were re-mated to produce the F1b and F2b litters, respectively.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Parental rats (P1 and F1 generation) were dosed daily for 100 days prior to cohabitation, during the cohabitation period (mating), during gestation, and during lactation, until the weaning of the offspring.
- Frequency of treatment:
- twice weekly
- Details on study schedule:
- - F1 parental animals not mated until 100 days after selected from the F1 litters.
- Selection of parents from F1 generation once pups were weaned (no age mentioned).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.0, 3.0, 4.0% in oxidative hair dye
Basis:
- No. of animals per sex per dose:
- F0: 40/sex/dose
F1: 20/ sex/dose - Control animals:
- yes, concurrent no treatment
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: reproductive effects
- Effect level:
- > 4 other: % test substance in oxidative hair dye
- Sex:
- male/female
- Basis for effect level:
- other: No effect on reproductive performance or on health and survival of developing foetus and postnatal animal.
- Remarks on result:
- other: Generation: F1a, F1b, F2a, F2b (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results of these studies, the frequent topical application of oxidative hair dyes does not appear to have an adverse effect on reproductive performance or on the health and survival of the developing foetus and postnatal animal.
- Executive summary:
A two-generation reproduction study was conducted in Sprague-Dawley rats receiving topical applications of oxidative hair-colouring formulations. These formulations were prepared as prototypes of permanent hair colourings using the base ingredients and primary intermediates and couplers most often used in this kind of product. Among the dyes included in the various formulations was the test substance at 2.0, 3.0, or 4.0%. The dye solutions were mixed with an equal volume of 6% hydrogen peroxide prior to application. In the reproduction study the samples were applied topically twice weekly throughout the growth, mating, gestation and lactation phases of the F0 parents to the weaning of the F1a and F2b litters. Fertility, gestation and foetal viability indices and body weights were evaluated and these were compared with the values for the three concurrent control groups. In the reproduction phase the application of hair dyes had no adverse effect on the fertility of the males or females, or on gestation, lactation and weaning indices. The average number weaned per litter and the mean body weights of the weanlings were comparable among the treated and control groups. On the basis of the results of the studies reported here the authors conclude that the frequent topical application of oxidative hair dyes containing the test substance and other commonly used intermediates and couplers has no adverse effects on reproduction.
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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