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EC number: 202-462-0 | CAS number: 95-88-5
- 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
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:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- TERATOLOGY AND PERCUTANEOUS TOXICITY STUDIES ON HAIR DYES
- Author:
- C. Burnett, E. I. Goldenthal, S. B. Harris, F. X. Wazeter, J. Strausburg, R. Kapp, R. Voelker
- Year:
- 1 976
- Bibliographic source:
- Journal of Toxicology and Environmental Health, 1:6, 1027-1040, 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Subchronic dermal toxicity study of 4-Chlororesorcinol (as part of mixture 7406) in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-chlororesorcinol
- EC Number:
- 202-462-0
- EC Name:
- 4-chlororesorcinol
- Cas Number:
- 95-88-5
- Molecular formula:
- C6H5ClO2
- IUPAC Name:
- 4-chlorobenzene-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): 4-Chlororesorcinol
- Molecular formula (if other than submission substance): C6H5O2Cl
- Molecular weight (if other than submission substance): 144.56 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Housing: Animals was housed in cages
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: Hydrogen peroxide
- Details on exposure:
- TEST SITE
- Area of exposure: Dorsolateral aspects of thoracic-lumbar area (one on each side of the midline) were exposed.
- % coverage: No data available
- Type of wrap if used: No data available
- Time intervals for shavings or clipplings: The hair at the site of application on the back and sides of each rabbit was clipped short throughout the study.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The rabbits were shampooed, rinsed and dried
- Time after start of exposure: 1 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml/kg
- Concentration (if solution): 1 ml/kg of 1:1 oxidation mixture were used.
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): Hydrogen peroxide was used
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): 6% hydrogen peroxide.
- Lot/batch no. (if required): No data available
- Purity: No data available
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes
The rabbits were restrained in holding stocks for 1 hr following each application - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Twice weekly (The application sites on three animals of each sex in each group were abraded on the first treatment day of each week).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 ml/kg (equivalent to 340 mg/kg)
Basis:
no data
- No. of animals per sex per dose:
- Control 1 : 6 male, 6 female
Control 2 : 6 male, 6 female
Control 3 (combined control) : 6 male, 6 female
1 ml/kg : 6 male, 6 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 1 ml/kg dose were applied as it was the maximum dose that could be applied on the side of the rabbits without runoff.
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked: Mortality was observed.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available.
DERMAL IRRITATION (if dermal study): No data available.
- Time schedule for examinations: No data available.
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: No data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION: No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood was collected on day 0, 3, 7and 13 of study.
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: All 48 animals were examined.
- Parameters checked in table [No.?] were examined: Blood count, methemoglobin, fasting blood sugar, HCT, Hb, RBC, WBC and Met-Hb were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood was collected on day 0, 3, 7and 13 of study.
- Animals fasted: No data available
- How many animals: All 48 animals were examined.
- Parameters checked in table [No.?] were examined: Glucose, BUN, Alkaline Phosphatase and SGOT were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: Urine was collected on day 0, 3, 7and 13 of study.
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined: Color, pH, albumin, glucose, occult blood, and microscopic elements were examined.
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: Organ weight was examined.
Organ weighed: Liver, kidneys, adrenals, heart, thyroid, spleen, brain, stomach, duodenum, colon, gall bladder, adrenals, eyes, pancreas, kidneys, urinary bladder, ovaries, testes, bone, bone marrow and lung were examined. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Gross abnormalities were examined by sacrificing all the treated animals at the termination of study.
HISTOPATHOLOGY: Yes
Organ was stained with hematoxylin and eosin and examined microscopically.
Organs examined: Skin from treated and untreated areas, lymph nodes (mesanteric, axillary, and cervical), spleen, stomach, duodenum, colon, liver, gall bladder, adrenals, nerve with adjacent muscle, eyes, pancreas, kidneys, urinary bladder, ovaries, testes, bone, bone marrow, heart, lung, thyroid, brain and skeletal muscle under the site of application and elsewhere (thigh) were examined - Other examinations:
- No data available
- Statistics:
- Statistical analysis was performed using the analysis of variance F test and Student's t test for body weight gains, hematology, clinical chemistries, and absolute and relative organ weights. When variances differed significantly, Student's t test was modified (t’) and Cochran's approximation was used.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No mortality were observed in treated rabbits as compared to control. Five control and five treated animals died during the study due to complications resulting from cardiac puncture while collecting blood for blood investigations. Clinical signs: No sign of toxicity was observed in treated rabbits as compared to control.
- Dermal irritation:
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated rabbits as compared to control. Five control and five treated animals died during the study due to complications resulting from cardiac puncture while collecting blood for blood investigations. Clinical signs: No sign of toxicity was observed in treated rabbits as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No body weight and weight gain was observed in treated rabbits as compared to control.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- In treated female rabbits, there was significant increase in RBC and significant decreased in Met-Hb and in male, significant decreased in Met-Hb was observed. However, these differences were not considered to be of toxicological significance.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Scattered statistically significant differences were observed in treated rabbits but were not considered to be of significance because of either the direction or continuity of the differences or because they fell in the range of historical control values.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No effect was observed in urine of treated rabbits as compared to control.
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- In treated rabbits, statistically significant differences in relative organ weight were observed as compared to combined control but the difference was not significant when compared with control.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross abnormalities were observed in treated animals
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic lesions were observed in treated rabbits as compared to control.
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No gross abnormalities were seen at necropsy and no microscopic examination that were judged to be due to the administration of the test compound. The incidence and severity of disease processes common to laboratory rabbits was not affected by the experimental treatments.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 340 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival, clinical sign, body weight, hematology, clinical chemistry, urine analysis, organ weight, gross pathology and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 340 mg/kg bw/day for New Zealand white male and female rabbits when treated with 4-Chlororesorcinol (as part of mixture 7406).
- Executive summary:
In subchronic dermal repeated dose toxicity study, male and female New Zealand white rabbits were exposed to 4–Chlororesorcinol in the concentration of 0 and 1 ml/kg (equivalent to 340 mg/kg bw/day).
The results showed that 4 -Chlororesorcinol was not toxic. No effect were observed on survival, no evidences of percutaneous toxicity, no changes in body weight, hematology, clinical chemistry and absolut and relative organ weight of treated animals. In addition, no gross pathological and histopathological changes were observed in treated rabbits.
Therefore, NOAEL was considered to be 340 mg/kg bw/day when New Zealand white male and female rabbits were exposed to 4-Chlororesorcinol (as part of mixture 7406) dermally for 13 weeks.
This value indicates that the substance is unlikely to exhibit repeated dose toxicity by the dermal route at the above mentioned dose level.
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