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EC number: 210-236-8 | CAS number: 610-81-1
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1992-03-05 to 1992-05-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test item is 6% diluted substance tested in vehicle instead of smallest amount of water (or, where necessary, of another suitable vehicle) in according to 404 OECD (adopted: 28 July 2015), no analytical certificate of the test substance available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- yes
- Remarks:
- yes The test substance is 6% diluted in vehicle. However, according to 404 OECD protocols (28 July 2015), a solid test substance has to be used with the smallest amount of water (or, where necessary, another suitable vehicle).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-3-nitrophenol
- EC Number:
- 210-236-8
- EC Name:
- 4-amino-3-nitrophenol
- Cas Number:
- 610-81-1
- Molecular formula:
- C6H6N2O3
- IUPAC Name:
- 4-amino-3-nitrophenol
- Test material form:
- solid: flakes
- Remarks:
- bown red flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: op 238
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was ground down to a fine dust and then suspended at a concentration of 6% in the 1,2-propanediol
- Final dilution of a dissolved solid, stock liquid or gel: 6% (w/w)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, France
- Age at study initiation: not specified
- Weight at study initiation: 2.4±0.05kg
- Housing: Individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): Certified pellet diet "Rabbits sustenance ref. 112C"(U.A.R., 91360 Villemoisson-sur-Orge, France). An analytical certificate of the quality of the food and the major food contaminants (pesticides, heavy metals, mycotoxins, etc.) was made available by the supplier and given for each batch.
- Water (e.g. ad libitum): Free access to tap water filtered by a 0.22 micron filtered membrane (Société Millipore, 78140 Velizy, France) and contained in water bottles. Bacteriological and chemical analyses of the water and detection of the major contaminants (pesticides, heavy metals and nitrosamines) were made periodically (laboratoire Municipal et Regional de Rouen, 76000 Rouen, France- Centre de nutrition humaine , 54000 Nancy France - Laboratoire Departemental d'analyses, 27000 Evreux, France)
- Acclimation period: at least 5 days during which they were observed daily
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3°C
- Humidity (%): 50±20% relative humidity
- Air changes (per hr): The air was non-recycled and filtered by absolute filters
- Photoperiod (hrs dark / hrs light): 12 hours of light/ 12 hours of dark
IN-LIFE DATES: From: 21 March 1992 To: 29 March 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 1,2-propanediol
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 6%
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.47 ml
- Concentration (if solution): 94%
- Lot/batch no. (if required): 1256840
- Purity:99% - Duration of treatment / exposure:
- 4 Hours
- Observation period:
- One hour, 24h, 48h, 72h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Preparation : The day before treatment, the flancks of each animal were partially clipped with an electric clipper. Only animals showing no obvious signs of irritation were used for the study.
- Application : A single dose of 0.5 ml of a solution containing the test substance at a concentration of 6% in 1.2-propanediol was applied to a 6cm² dry hydrophilic gauze patch (Semes France, France) and this was then applied to the right flank of each animal.
- Area of exposure: 6 cm²
- Type of wrap if used: adhesive hypoallergic aerated semi-occlusive dressing (Laboratoires de Pansements et d'Hygiène, France)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing were removed and residual test substance was removed with a gauze patch saturated with water for injections batch n° 1343 (Biosédra, France).
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours
SCORING SYSTEM:
- Method of calculation:
Oedema Formation
No oedema ..........................................................................................................................0
Very slight oedema (barely perceptible)..............................................................................1
Slight oedema (edges of area well defined by definite raising) ..........................................2
Moderate oedema (raised approximately 1millimetre) ..........................................................3
Severe oedema (raised more than 1 millimetre and extended beyond area of exposure) ..4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Mean calculated score for each site
- Time point:
- other: 1/24/48/72H
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Mean calculated score for each site
- Time point:
- other: 1/24/48/72H
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- Possible erythema was obscured by colouration caused by the residual test substance.
- Irritant / corrosive response data:
- Macroscopic examination: no edema was noted. Possible erythema was obscured by colouration caused by the residual test substance.
Microscopic examination: slight dermal inflammatory cell aggregation was noted in 1 animal. This type of lesion can be found spontaneously in the laboratory rabbit and is considered to be of no toxicological importance.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this study, the test item at 6% in 1.2-propanediol caused no edema to rabbit skin and no lesions related to the application of the test item were noted at the microscopic examination. The study cannot be used for classification. Indeed, the test dose is 6% in diluted vehicle instead of pure or with the smallest amount of water (or,where necessary, of another suitable vehicle) according to REACh and CLP regulation.
- Executive summary:
This GLP-compliant study was performed to assess the potential of the test material to induce skin
irritation in vivo, according to OECD Guideline 404 (dated May 12, 1981). 0.5 ml of 6% test substance diluted in 1.2 propanediol were applied under semi-occlusive dressing during 4 hours, on a shaved skin area (right flank) of 3 male rabbits. The left flank served as a control. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after the removal of the dressing. Results: Macroscopic examination: no edema was noted. Possible erythema was obscured by colouration caused by the residual test substance. Microscopic examination: slight dermal inflammatory cell aggregation was noted in 1 animal. This type of lesion can be found spontaneously in the laboratory rabbit and is considered to be of no toxicological importance.
The study cannot be used for classification. Indeed, the test dose is 6% in diluted vehicle instead of pure or with the smallest amount of water (or, where necessary, of another suitable vehicle) according to REACh and CLP regulation.
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