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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- TERATOLOGY AND PERCUTANEOUS TOXICITY STUDIES ON HAIR DYES
- Author:
- Burnett C, Goldenthal EI, Harris SB, Wazeter FX, Strausburg J, Kapp R, Voelker R.
- Year:
- 1 976
- Bibliographic source:
- J Toxicol Environ Health. 1976. 1(6): 1027-1040.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
The chronic toxicological potential following skin painting in mice was evaluated for oxidative and nonoxidative hair dyes formulation together with a control groups which were shaved only and received no applications
- Short description of test conditions: dermal exposure was assessed; groups of male and female Swiss mice were treated one time weekly for at least 20 mo with one dose level of each dye. The oxidative dyes were mixed 1:1 with 6% hydrogen peroxide before treatment and the three semipermanent formulations were applied without dilution
- Parameters analysed / observed: Toxicological and carcinogenic effects were analysed - 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:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
The Clairol Research Laboratories (Stamford, Conn.) provided seven oxidative hair dye formulations, which were identified as 7401, 7402, 7403, 7404, 7405, 7406, and P-21. They also provided three semipermanent
hair dye formulations, coded P-22, P-23, and P-24. The remaining two oxidative hair dye formulations, P-25 and P-26, were provided by L'Oreal Inc. (Clark, N.J.).
- Expiration date of the lot/batch:
not specified
- Purity test date:
not specified
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
not applicable
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
not specified
- Stability under test conditions:
not specified
- Solubility and stability of the test substance in the solvent/vehicle:
not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
not specified
- Preliminary purification step (if any):
not specified
- Final dilution of a dissolved solid, stock liquid or gel:
not specified
- Final preparation of a solid:
not specified
FORM AS APPLIED IN THE TEST (if different from that of starting material): solutions
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): not applicable
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: The mated females were housed individually in temperature- and humidity-controlled rooms during the study and were weighed on the days the dyes were administered.
- Diet (e.g. ad libitum): Ralston Purina Laboratory Chow available ad libitum.
- Water (e.g. ad libitum): available ad libitum.
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To: not specified
Administration / exposure
- Route of administration:
- dermal
- Remarks on MMAD:
- not relevant: the substance was applied topically
- Details on exposure:
- TEST SITE
- Area of exposure: The hair at the site of application on the dorso-scapular area was shaved closely the day before the solutions were applied
- % coverage: not specified
- Type of wrap if used: not specified
- Time intervals for shavings or clipplings: not specified
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): not specified
- Constant volume or concentration used: yes/no not specified
- For solids, paste formed: yes/no not specified
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes/no - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- not specified
- Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- not specified
- Duration of test:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 other: ml/kg
- Remarks:
- dose of formulation applied (pyrogallol was a constituent of the formulation named P-21: 0.4%)
- Dose / conc.:
- 8 mg/kg bw/day
- Remarks:
- calculated pyrogallol dose
- No. of animals per sex per dose:
- 20 (only female)
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: previous pitol study
- Rationale for animal assignment (if not random): random
- Other: -
Examinations
- Maternal examinations:
- not relevant
- Ovaries and uterine content:
- The uteri were examined, corpora lutea of pregnancy counted, and the number, distribution, and location of live, dead, and resorbed fetuses
recorded. - Fetal examinations:
- All fetuses were examined for gross anomalies, sexed, and weighed. Approximately one-third the fetuses from each litter were fixed in Bouin's solution and subsequently examined for visceral anomalies by razor blade sectioning (Wilson and Warkany, 1965). The remaining fetuses
in each litter were fixed in 95% ethyl alcohol, eviscerated, cleared, stained with KOH-alizarin red S (Staples and Schnell, 1964), and examined for skeletal anomalies. Fetal examinations were performed in a random order with treatment group identity unknown to the examiner - Statistics:
- All statistical analyses compared the treatment groups with the control groups. The number of females exhibiting resorption sites, number of females exhibiting two or more resorptions, number of dead or resorbed fetuses, and the number of fetuses with soft-tissue or skeletal anomalies and accessory ribs was compared using chi-square test criterion with Yates' correction on 2 X 2 contingency tables as described by Steel and Torrie (1960) or Fisher's exact probability test (Siegel, 1956) as appropriate to judge the significance of difference.
The mean number of corpora lutea, implantation sites, live fetuses, and resorption sites was compared by analysis of variance (one-way classification)
as described by Steel and Torrie (1960) using Dunnett's (1964) multiple comparison tables to judge the significance of differences.
The live fetal weights were compared by analysis of variance (hierarchal classification) as described by Steel and Torrie (1960) using Dunnett's (1964) multiple comparison tables to judge the significance of differences.
Statistically significant differences between groups were judged valid only when there were significant differences between any one of the dye treated groups and each of the three untreated control groups. - Indices:
- not specified
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Changes in female body weights were similar for rats in the untreated controls and all dye-treated groups
Mean food consumption for all groups throughout gestation was similar. - Details on maternal toxic effects:
- Maternal toxicity was not observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Effects observed for a formulation no-pyrogallol-containing.
- Visceral malformations:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- fetal soft tissue anomalies: no significant differences.
- Details on embryotoxic / teratogenic effects:
- not reported
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 8 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- changes in sex ratio
- skeletal malformations
- Remarks on result:
- other: no embryotoxic or teratogenic effects observed at the dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- no embryotoxic or teratogenic effects.
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 8 mg/kg bw/day
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- No significant differences in the number of corpora lutea, implantation sites, live fetuses, resorptions, or fetal soft tissue or skeletal anomalies were induced.
The teratogenicity of a hair dye formulation containing 0.4% Pyrogallol was evaluated using 20 Charles River CD female rats. The hair dye (2 ml/kg) was applied to the dorsoscapular area (shaved skin) of each animal on days 1,4, 7, 10, 13, 16, and 19 of gestation. Three groups of untreated rats (unshaved) served as controls. Animals in the positive control group were given acetylsalicylic acid (250 mg/kg) via gavage on days 6 to 16 of gestation. The dams were killed on day 20 of gestation via chloroform anesthesia, and fetuses were removed via cesarean section. One third of the fetuses from each litter were examined for visceral anomalies. The remaining fetuses were examined for skeletal anomalies. Toxic effects were not observed in experimental or control dams throughout the study. The mean numbers of corpora lutea, implantation sites, and live fetuses in experimental groups were not significantly different from those in control groups. There were also no significant differences in the nurnber of females with resorption sites and the mean number of resorptions per pregnancy. The incidence of fetal soft tissue and skeletal anomalies in experimental groups was not significantly different from that of negative control groups. A significant increase in the number of fetuses with skeletal and soft tissue anomalies and in the number of dead or resorbed fetuses was observed in the positive control group - Executive summary:
Twelve hairdye formulations were tested by topical application twice weekly for 13 wk for teratologic effects following applications to groups of 20 pregnant Charles River CD rats on days 1, 4, 7, 10, 13, 16, and 19 of gestation. The three semipermanent formulations were applied as is, and the nine oxidationdyes were mixed 1:1 with 6% hydrogen peroxide just prior to application, as in normal use. The formulations induced a broad spectrum of dye sand dye intermediates used or considered useful in oxidative and semipermanent haircolor products. In theteratology study no biologically significant soft tissue or skeletal changes were noted. Similarly, the mean numbers of corpora lutea, implantation sites, live fetuses, and resorptions per pregnancy, as well as numbers of litters with resporptions, were not significantly affected by the dye treatment.
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