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EC number: 228-762-1 | CAS number: 6358-09-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 21, 1988 to July 15, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report, followed basic scientific principles/methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Limit Test
- Principles of method if other than guideline:
- Acute oral toxicity or LD50 value was determined by oral administration of 20% aqueous solution of the test substance to a single dose group (limit dose of 2000 mg/kg bw) of male and female rats. Post-dosing, animals were observed for mortality and signs of toxic and pharmacologic effects for 14 days. The survivors were necropsied after 14 days and observed for gross lesions. The method followed in this study was based on the OECD guideline 401.
- GLP compliance:
- yes
- Remarks:
- according to OECD principles of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-amino-6-chloro-4-nitrophenol
- EC Number:
- 228-762-1
- EC Name:
- 2-amino-6-chloro-4-nitrophenol
- Cas Number:
- 6358-09-4
- Molecular formula:
- C6H5ClN2O3
- IUPAC Name:
- 2-amino-6-chloro-4-nitrophenol
- Reference substance name:
- Chlororange Base
- IUPAC Name:
- Chlororange Base
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: 2-Amino-6-chloro-4-nitrophenol, Chlororange
- TSIN: COS 198
- Substance type: Pure active substance
- Physical state: Orange- yellow fine grained powder
- Stability under test conditions: Not reported
- Storage condition of test material: Normal room temperature, in darkness
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Wella AG, n°batch : COS 198
- Expiration date of the lot/batch: No data
- Purity test date: No data
- Purity : 100 area% (HPLC at 254 nm)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: normal room temperature, in darkness
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING :
- Treatment of test material prior to testing: Yes (dllution)
- Final dilution of a dissolved liquid : 20%
Test animals
- Species:
- rat
- Strain:
- other: Crl.:(WI) BR - Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld
- Age at study initiation: Not reported
- Weight at study initiation: Males : 196 - 228 g; Females : 176 - 205 g
- Fasting period before study: 16 hours before administration of the test sample
- Housing: Collective caging, macrolon type III/max. 5
- Bedding: H-3/4 produced from pure soft wood, dried, disdusted and sterilized at 180°C
- Diet: Pellets (2.4 cm long, 1.0 diameter); Ssniff- R Alleindiet for rats; ad libitum
- Water: Aqua fontana as for human consumption in Macrolon drinking bottles; ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Humidity: 50 - 80%
- Air changes: Not reported
- Photoperiod: 12 hours daily, from 7.00 a.m. - 7.00 p.m.; fluorescent light, 120 lux
IN-LIFE DATES: From June 21, 1988 to July 15, 1988
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- DOSAGE: The test compound was applied as a 20 % dilution in aqua deion.
TREATMENT: After being fasted for approximately 16 hours, the animals were administered single dose of test substance orally by stomach tube. Food was presented after 4 hours of dosing.
MAXIMUM DOSE VOLUME APPLIED: 2.3 mL - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made at the following intervals: about 20 minutes, 1 +2 h, 3+6 h, 24/48 h, thereafter once daily up to Day 14. The body weights are recorded at Day 0, at Day 7 and at Day 14 on the surviving animals.
- Necropsy of survivors performed: yes, all surviving animals were subjected to complete gross necropsy following their sacrifice at the end of Day 14 or spontaneous death.
RANGE FINDING STUDY: Yes, a range finding study was conducted using 2 female rats at a single dose of 2000 mg/kg bw. No mortality was observed in this range finding study. Based on this result, 2000 mg/kg bw was used as a maximum dosage (limit dose) for the main study.
- Statistics:
- As no mortality was observed, statistical analysis cannot be performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortalities were observed
- Clinical signs:
- Red-orange-stained bedding (urines red-orange-stained) was observed up to 5 days
- Body weight:
- Normal weight gain was observed
- Gross pathology:
- No macroscopic findings were observed in the cranial, thoracic and abdominal cavity.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity (LD50) of Chlororange (2-Amino-6-chloro-4-nitrophenol) was > 2000 mg/kg bw in male and female rats. Therefore, this test substance is not classified according to EU criteria for classification.
- Executive summary:
The objective of this study was to determine the acute oral toxicity (LD50) of Cholorange (2-Amino-6-chloro-4-nitrophenol) when administered once orally to male and female rats.Crl.:(WI) BR - Wistar rats.
Ten animals (5 males and 5 females) obtained from Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld were used in this study. The animals were housed in groups of 5 in Makrolon type-3 cages with standard softwood bedding. Pelleted Ssniff- R Alleindiet and aqua fontana water were provided ad libitum. The animals were maintained according to standard laboratory conditions (temperature: 20 ± 2°C, relative Humidity: 50 – 80%, photoperiod: 12 h artificial fluorescent light/12 h dark). Animals were acclimated for one week and fasted for 16 h prior to dosing.
The test substance was administered as a 20% dilution in aqua deion to animals orally by stomach tube at a limit dose of 2000 mg/kg bw.
Post treatment, animals were examined for mortality and clinical signs at about 20 minutes, 1h, 2 h, 3h, 6 h, 24h, 48 h and thereafter once daily up to Day 14. Body weights were recorded on Day 0, Day 7 and on Day 14. After 14 days of observation, all surviving animals were subjected to complete gross necropsy following their sacrifice at the end of Day 14 or spontaneous death. No mortality was observed during the study. Red-orange-stained bedding (urines red-orange-stained) was observed up to 5 days post administration.Body weights changes after each observation period showed a normal weight gain. No macroscopic findings were noted during necropsy.
Based on above, the acute oral toxicity (LD50) of Cholorange was determined to be > 2000 mg/kg bw. Therefore, this test substance is not classified according to EU criteria for classification.
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