Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-762-9 | CAS number: 87-66-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Pyrogallol
- Author:
- CIR - COSMETIC INGREDIENT REVIEW
- Year:
- 1 991
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY. 10(1): 67-85
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
- Short description of test conditions:
- Parameters analysed / observed: - GLP compliance:
- not specified
Test material
- Reference substance name:
- Pyrogallol
- EC Number:
- 201-762-9
- EC Name:
- Pyrogallol
- Cas Number:
- 87-66-1
- Molecular formula:
- C6H6O3
- IUPAC Name:
- benzene-1,2,3-triol
- Reference substance name:
- unknown impurities
- IUPAC Name:
- unknown impurities
- Test material form:
- not specified
- Details on test material:
- not specified
Constituent 1
impurity 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (0.5 ml) to the skin twice per week throughout mating, gestation, and during the period of lactation to weaning of the F1b, F2b, and F3b litters of the respective generations.
- Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- twice per week
- Details on study schedule:
- no data
Doses / concentrations
- Remarks:
- no data available
- No. of animals per sex per dose:
- A total of 40 males and 40 females were tested
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- Fertility, gestation, and viability indices
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats.
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.002 other: mg/animal
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- reproductive performance
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.002 other: mg/animal
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1b
- Effect level:
- 0.002 other: mg/animal
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats.
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2b
- Effect level:
- 0.002 other: mg/animal
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Treatment related:
- no
Any other information on results incl. tables
There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring.
Mild skin reactions, in treated animals, were noted intermittently throughout the study.
Fertility, gestation, and viability indices were comparable between control and experimental groups.
Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats
Applicant's summary and conclusion
- Conclusions:
- A multigeneration reproduction study in rats was conducted in males and females dermally exposed to a hair dye formulation that contained 0.4% Pyrogallol.
There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring. However, mild skin reactions, in treated animals, were noted intermittently throughout the study. Fertility, gestation, and viability indices were comparable between control and experimental groups. Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats. - Executive summary:
A multigeneration reproduction study was conducted using Charles River CD rats.
A total of 40 males and 40 females were tested with a hair dye formulation that contained 0.4% Pyrogallol. The dye was mixed with an equal volume of 6% hydrogen peroxide and applied (0.5 ml) to the skin twice per week throughout mating, gestation, and during the period of lactation to weaning of the F1b, F2b, and F3c, litters of the respective generations. There were no treatment-related changes in general behavior and appearance, body weight, or survival in parents or offspring. However, mild skin reactions, in treated animals, were noted intermittently throughout the study. Fertility, gestation, and viability indices were comparable between control and experimental groups. Additionally, there were no treatment-related gross or microscopic lesions observed in F1b parental rats or F3b weaning rats.
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.