Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 8 December to 27 January 2005
- 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 study
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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted : 24th April 2002
- Deviations:
- yes
- Remarks:
- on day 1, one animal had a body weight higher than 3.5 kg (3924 g). This minor deviation was not considered to have compromised the validity or integrity of the study.
- Principles of method if other than guideline:
- An eye irritation study was performed to assess a potential irritation or corrosion property of the test substance (m-Aminophenol) on New Zealand White rabbit after according to OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
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: batch No. 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:white powder in glass flask at +4°C, protected from light and under nitrogen gas
- Stability under test conditions: known solubility but not reportered in this study (CIT/Study No. 26941 AHS).
- Solubility and stability of the test substance in the solvent/vehicle: known solubility but not reportered in this 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% 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 3.2 ± 0.6 kg.
- Housing: 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), ad libitum. 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.
IN-LIFE PERIOD : From 6 to 11 April 2004
Test system
- Vehicle:
- other: 0.5% suspension of methylcellulose
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single dose of 0.1 mL
- Concentration (if solution): At a concentration of 2% in vehicle
VEHICLE
- Concentration (if solution): 2% - Duration of treatment / exposure:
- The study was ended on day 4 in the absence of persistent ocular reactions.
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours after administration of the test item.
- Number of animals or in vitro replicates:
- Three male rabbits were used in the study.
- Details on study design:
- TREATMENT
Selection of the animals
The day before treatment, the eyes of each animal were examined in order to check the absence of any signs of ocular irritation, ocular defects or pre-existing corneal injury.
Administration of the test item
At the request of the Sponsor, the test material was used at the concentration of 2% in the vehicle. The dosage form was first administered to a single animal. Since the test item was not irritant on the first animal, it was then evaluated on two other animals. A single dose of 0.1 mL of the test item at the concentration of 2% was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated, served as control. The eyes were not rinsed after administration of the test item
REMOVAL OF TEST SUBSTANCE
- Washing : The eyes were not rinsed after administration of the test material.
TOOL USED TO ASSESS SCORE: Conjunctival reactions, iritis and corneal opacification were evaluated daily for each animal. For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
SCORING: Ocular reactions were scored according to the following numerical scale:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling ...............................................................................................................................0
. any swelling above normal (includes nictitating membranes) .................................................1
. obvious swelling with partial eversion of lids..........................................................................2
. swelling with lids about half-closed.........................................................................................3
. swelling with lids more than half-closed..................................................................................4
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal ................................................................................................................0
. a number of blood vessels definitely hyperemic (injected)......................................................1
. diffuse, crimson colour, individual vessels not easily discernible ...........................................2
. diffuse, beefy red......................................................................................................................3
Discharge
. absence of discharge.................................................................................................................0
. slight discharge (does not include small amounts normally found in
inner canthus) ...........................................................................................................................1
. discharge with moistening of lids and hairs adjacent to lids....................................................2
. discharge with moistening of lids and hairs on wide area around the eye ...............................3
Iris lesions
. normal ......................................................................................................................................0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia, or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction is positive) ........................................................................1
. no reaction to light, haemorrhage, gross destruction (any or all of these) ...............................2
Corneal lesions
Degree of opacity (area most dense taken for reading)
. no ulceration or opacity............................................................................................................0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible......................................................................................................1
. easily discernible translucent area, details of iris slightly obscured.........................................2
. nacreous areas, no details of iris visible, size of pupil barely discernible................................3
. opaque cornea, iris not discernible through the opacity...........................................................4
Area of opacity
. one quarter (or less) but not zero..............................................................................................1
. greater than one quarter but less than a half.............................................................................2
. greater than one half but less than three quarters .....................................................................3
. greater than three quarters up to whole area.............................................................................4
Any other lesions observed were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- A very slight chemosis and a very slight redness of the conjunctiva were observed in 2/3 animals on day 1. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.
Any other information on results incl. tables
Table 1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number |
Region of eye |
Description of ocular reactions |
Scores |
Mean irritation score (1) |
|||
1h 24h 48h 72h |
|||||||
|
|
|
D1 |
D2 |
D3 |
D4 |
|
889 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
|
Redness |
0 |
0 |
0 |
0 |
0.0 |
|
|
Discharge |
0 |
0 |
0 |
0 |
0.0 |
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
|
Area |
0 |
0 |
0 |
0 |
0.0 |
|
Other Fluorescein |
|
* |
* U |
* |
* |
|
|
/ |
/ |
/ |
|||||
848 |
Conjunctivae |
Chemosis |
1 |
0 |
0 |
0 |
0.0 |
|
Redness |
1 |
0 |
0 |
0 |
0.0 |
|
|
Discharge |
0 |
0 |
0 |
0 |
0.0 |
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
|
Area |
0 |
0 |
0 |
0 |
0.0 |
|
Other Fluorescein |
|
* |
* U |
* |
* |
|
|
/ |
/ |
/ |
|||||
849 |
Conjunctivae |
Chemosis |
1 |
0 |
0 |
0 |
0.0 |
|
Redness |
1 |
0 |
0 |
0 |
0.0 |
|
|
Discharge |
E |
0 |
0 |
0 |
0.0 |
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
|
Area |
0 |
0 |
0 |
0 |
0.0 |
|
Other Fluorescein |
|
* |
* U |
* |
* |
|
|
/ |
/ |
/ |
(1) mean of scores on days 2, 3 and4 h =hour
D = day
* = none
U = fluorescein batch No. H586
/ = fluorescein not used
E = scoring masked by residual test item
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 well-tolerated when administered by ocular route to rabbits. Hence the test chemical m-Aminophenol (CAS No: 591-27-5) was considered to be not irritating to the treated eyes of New Zealand White rabbits.
- Executive summary:
The eye irritation study was performed to assess a potential irritation or corrosion property of the test substance (m-Aminophenol) on New Zealand White rabbit after according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).
The dosage form was first administered to a single male New Zealand White rabbit. Since it was not irritant on this first animal, it was then evaluated in two other animals. A single dose of 0.1 mL of the test item at the concentration of 2% was instilled into the left conjunctival sac. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.
Instillation into the conjunctival sac of 3 New Zealand White rabbits resulted in very slight chemosis and very slight conjunctival redness in 2/3 animals on the day of dosing only. No ocular reactions were observed during the remainder of the study. Accordingly, 2% m-aminophenol produced minimal conjunctival reactions which were rapidly reversible and was thus considered to be non-irritating.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.
Under the experimental conditions, the test material m-Aminophenol (batch No. 220117) at the concentration of 2% in a 0.5% suspension of methylcellulose is well-tolerated when administered by ocular route to male rabbits. Hence the test chemical m-Aminophenol (CAS No: 591-27-5) was considered to be not irritating to the treated eyes of New Zealand White rabbits.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.