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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 202-767-9 | CAS number: 99-57-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratology and percutaneous toxicity studies on hair dyes
- Author:
- C. Burnett
- Year:
- 1 976
- Bibliographic source:
- Journal of Toxicology and Environmental Health
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Thirteen week study was conducted to evaluate the toxic effects of repeated administration of test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-amino-4-nitrophenol
- EC Number:
- 202-767-9
- EC Name:
- 2-amino-4-nitrophenol
- Cas Number:
- 99-57-0
- Molecular formula:
- C6H6N2O3
- IUPAC Name:
- 2-amino-4-nitrophenol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: 6% Hydrogen peroxide
- Details on exposure:
- TEST SITE
The sites of application on the dorsolateral aspects of the thoracic-lumbar area (one on each side of the midline) were alternated to minimize skin irritation.
REMOVAL OF TEST SUBSTANCE
The rabbits were restrained in holding stocks for 1 hr following each application and were then shampooed, rinsed, dried, and returned to their cages
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test materials, prepared by mixing equal volumes of the dye solution and 6% hydrogen peroxide, were applied topically at a dose of 1000 mg/kg (
1 ml/kg) application.
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Twice weekly
Doses / concentrations
- Remarks:
- 1000 mg/kg (1 ml/kg)
- No. of animals per sex per dose:
- Control – I: 6male and 6 females
Control - II : 6male and 6 females
Control - III: 6male and 6 females
2-Amino-4-nitrophenol : 6male and 6 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- The hair at the site of application on the back and sides of each rabbit was clipped short throughou
t the study. The application sites on three animals of each sex in each group were abraded on the f
irst treatment day of each week. The rabbits were restrained in holding stocks for 1 hr following each
application and were then shampooed, rinsed, dried, and returned to their cages.
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed and frequency
BODY WEIGHT: Yes,
The animals were weighed weekly during the study.
HAEMATOLOGY: Yes
Hematologic determinations was performed on all animals at 0, 3, 7, and 13 wk.
Following parameters was examined :
Blood count, Methemoglobin, Fasting blood sugar
CLINICAL CHEMISTRY: Yes
Clinical chemistry determinations was performed on all animals at 0, 3, 7, and 13 wk.
Following parameters was examined :
Blood urea nitrogen, Alkaline phosphatase, Serum glutamic oxaloacetic transaminase
URINALYSIS: Yes
Examination of urine was performed on all animals at 0, 3, 7, and 13 wk.
Urine was examined for color, pH, albumin, glucose, occult blood, and microscopic elements.
OTHER: Organ weights was determined. - Sacrifice and pathology:
- All survivors were sacrificed after 13 wk and examined for gross abnormalities. Organ-body weight ra
tios were determined for liver,kidneys, adrenals, heart, thyroid, spleen, and brain.
Twenty-five tissues were examined microscopically.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Statistical analysis of the data on body weight gains, hematology, clinical chemistry, and absolute and relative organ weights was performed using the analysis of variance F test and Student's t test.When variances differed significantly, Student's t test was modified (t')and Cochran's approximation was utilized.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significant clinical sign was obsrved at dose level of 1000 mg/kg of treated group compare to control.
- Dermal irritation:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Five control and five test animals died during the study due to complications resulting from cardiac puncture while collecting blood.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant clinical sign was obsrved at dose level of 1000 mg/kg of treated group compare to control.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No effects (There were scattered statistically significant differences in the hematologic values between test and control groups at the various sampling intervals. However, these differences were
not considered to be of toxicologic significance because of either the direction or continuity of the differences or the fact that they fell within the range of historical control values.) - Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were a few instances when there were statistically significant differences in relative organ weights between a test group and the combined controls but the differences were not significant when they were compared with each control group separately.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic lesions were seen that were judged to be due to the administration of the hair dye formulations.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed at this dose
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/day for test chemical in New Zealand White male and female rabbit for 13 weeks by dermal route.
- Executive summary:
Thirteen week study was conducted to evaluate the toxic effects of test substance. Test substance was applied dermally twice weekly for 13 week to groups of 12 adult New Zealand white male and female rabbits at a dose concentration of 1000 mg/kg. The animals were observed for dermal irritation,clinical sign, mortality, body weight, organ weight, gross and histopathology.There was no evidence of induced systemic effects. No effects on body weight. Microscopic examination of 25 tissues from each animal gave no indication of histomorphologic evidence of toxicity. No gross abnormalities were seen at necropsy. No dye discoloration of urine was seen at any time during the test or at necropsy.
Therefore NOAEL of the study was considered to be 1000 mg/kg for test chemical in New Zealand White male and female rabbit for 13 weeks by dermal route.
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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