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EC number: 209-711-2 | CAS number: 591-27-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 30 March 2004 to 4 April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, GLP-compliant
- Justification for type of information:
- Data is from experimental report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted : 28 July 2015
- Deviations:
- yes
- Remarks:
- Test item concentration apllied was only at 2%, not in accordance with REACh requirements
- Principles of method if other than guideline:
- Skin irritation of test chemical m-Aminophenol (CAS No: 591-27-5) was conducted on New Zealand White rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-aminophenol
- EC Number:
- 209-711-2
- EC Name:
- 3-aminophenol
- Cas Number:
- 591-27-5
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 3-aminophenol
- Reference substance name:
- m-Aminophenol
- IUPAC Name:
- m-Aminophenol
- Test material form:
- solid: flakes
- Remarks:
- white to beige flakes
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: 220117
- Expiration date of the lot/batch: September 2005
- Purity test date: 31 August 2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +4°C, protected from light and under nitrogen gas
- Stability under test conditions: not specified in the report but known stability according previous performed study(CIT/Study No. 26941 AHS)
- Solubility and stability of the test substance in the solvent/vehicle: not specified in the report but known stability according previous performed study(CIT/Study No. 26941 AHS)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
On the day of treatment, the test item was first ground to a fine powder using a mortar and pestle and then prepared at the concentration of 2% (w/w) in the vehicle Before preparation, the vehicle was degassed by sonication for at least 30 minutes. The test item dosage forms were prepared extemporaneously under nitrogen atmosphere and were stored protected from light (using a glass beaker covered with aluminium foil) and under
nitrogen atmosphere until delivery. They were used within the 6 hours following the preparation.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: had a mean body weight ± standard deviation of 2.9 ± 0.5 kg.
- Housing: The animals were housed individually in polystyrene cages. Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): During the study, animals had access to 110 pelleted diet (SAFE, Villemoisson,
Epinay-sur-Orge, France). Food is analysed regularly by the supplier for composition and contaminant levels.
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines).
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h. The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.5% suspension of methylcellulose
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dose of 0.5 mL
- Concentration (if solution): At a concentration of 2% in vehicle
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of a 0.5% suspension of methylcellulose.
- Concentration (if solution): 0.5% in water - Duration of treatment / exposure:
- The dosage was first evaluated on a single animal. The duration of exposure was 3 minutes on the anterior left flank, 1 hour on the right anterior flank and 4 hours on the posterior right flank.
Since the dosage form was not irritant on the first animal, it was then applied for 4 hours on two other animals.
The study was ended on day 4 in the absence of persistent irritation reactions. - Observation period:
- 1 hour, 24, 48 and 72 hours
- Number of animals:
- three rabbits were used
- Details on study design:
- TREATMENT
Preparation and selection of the animals
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation.
Application of the test item
At the request of the Sponsor, the test material was used at the concentration of 2% in vehicle. The duration of exposure was 3 minutes on the anterior left flank, 1 hour on the anterior right flank and 4 hours on the posterior right flank. Since the dosage form was not irritant on this first animal, it was then applied for 4 hours to two other animals. Doses of 0.5 mL of the dosage form were placed on a dry gauze pad, which was then applied to the posterior right flank (application for 4 hours), to the anterior right flank (application for 1 hour) or the left flank (application for 3 minutes) of the animals.
The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control.
No residual test item was observed on removal of the dressing.
SCORING
Dermal irritation was evaluated for each animal according to the following scoring scale:
Erythema and eschar formation:
. no erythema........................................................................................................... 0
. very slight erythema (barely perceptible) ............................................................. 1
. well-defined erythema........................................................................................... 2
. moderate to severe erythema................................................................................. 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth)...... 4
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 1 millimetre) ........................................ 3
. severe oedema (raised more than 1 millimetre and extending beyond area
of exposure)........................................................................................................... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- After a 3-minute exposure (one animal):
No cutaneous reactions were observed.
After a 1-hour exposure (one animal):
A very slight erythema (grade 1) was noted on day 1, only.
After a 4-hour exposure (three animals):
No cutaneous reactions were observed.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Any other information on results incl. tables
TABLE : 4-hour exposure - Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit Number
|
Dermal Irritation |
Scores |
Mean Irritation score (1) |
|||
1 h |
24 h |
48 h |
72 h |
|
||
D1 |
D2 |
D3 |
D4 |
|
||
889 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
||||||
848 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
||||||
849 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
(1) mean of scores on days 2, 3 and 4 h = hour D = day * = none |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Under our experimental conditions, the test item m-Aminophenol (A015) (batch No. 220117) at the concentration of 2% in a 0.5% suspension of methylcellulose is non-irritant when applied to rabbit skin.
- Executive summary:
The skin irritation study was performed to assess a potential irritation or corrosion property of the test substance (m-Aminophenol) on New Zealand White rabbit after a 4h skin contact period, according to OECD 404 guideline method for acute dermal irritation/corrosion.
The dosage form was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since it was not irritant on this first animal, it was then applied for 4 hours to two other animals.
A single dose of 0.5 mL of the test item at the concentration of 2% was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.
Only a very slight erythema was noted on day 1 and no cutaneous reaction was observed at the other timepoints.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Under our experimental conditions, the test item m-Aminophenol (A015) (batch No. 220117) at the concentration of 2% in a 0.5% suspension of methylcellulose is non-irritant when applied to rabbit skin..
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