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EC number: 220-618-6 | CAS number: 2835-95-2
- 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data provided, followed scientific principles standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42, Test for eye irritants.
- Deviations:
- yes
- Remarks:
- only 3 animals were included in the study while guideline recommends 6 animals. The eyes were washed 10 sec. after instillation of the test material while guideline recommends no wash.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- 5-amino-o-cresol
- EC Number:
- 220-618-6
- EC Name:
- 5-amino-o-cresol
- Cas Number:
- 2835-95-2
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 5-amino-2-methylphenol
- Reference substance name:
- 4-amino-2-hydroxytoluene
- IUPAC Name:
- 4-amino-2-hydroxytoluene
- Test material form:
- not specified
- Details on test material:
- - Name of test material: 4-amino-2-hydroxytoluene
No other information on ‘details of test material’ were provided in the study report.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- No information on the details on ‘test animals and environmental conditions’ were provided in the study report.
Test system
- Vehicle:
- other: 0.5% aqueous gum tragacanth containing 0.05 % sodium sulphite (pH: 7.0)
- Controls:
- other: additional control animals are not required. untreated eye, served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 2.5% w/v solution
VEHICLE
- Concentration: 0.5% aqueous gum tragacanth containing 0.05 % sodium sulphite (pH: 7.0)
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- Eyes were examined at 1 hour, and at Day 1, 2, 3, 4, and 7 post application
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Yes; post exposure, the eyes were washed with 50 mL lukewarm (37°C) water.
- Time after start of exposure:10 Seconds
SCORING SYSTEM: The eye irritation were scored according to the following scale:
CORNEA
- No ulceration or opacity = 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible = (1)*
- Easily discernible translucent areas, details of iris slightly obscured = 2
- Nacreous areas, no details of iris visible, size of pupil barely discernible = 3
- Complete corneal opacity, iris not discernible = 4
IRIS
- Normal = 0
- Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof). Iris still reacting to light (sluggish reaction is positive) = (1)*
- No reaction to light, hemorrhage, gross destruction (any or all of these) = 2
CONJUNCTIVAE
Redness (Refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal = 0
- Some vessels definitely injected = 1
- Diffuse, crimson red, individual vessels not easily discernible (2)*
- Diffuse beefy red = 3
Chemosis
- No swelling = 0
- Any swelling above normal (including nictating membrane) = 1
- Obvious swelling with partial eversion of lids = (2)*
- Swelling with lids about half closed = 3
- Swelling with lids more than half closed = 4
*Bracketed figures indicate lowest grades considered positive under Title 16, Section 1500.42 of the Code of Federal Regulations.
-TOOL USED TO ASSESS SCORE: Not reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All animals with grade 0 cornea score
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: All animals with grade 0 iris score
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: All animals exhibited grade 1 conjunctivae (redness) score at 1 hour observation point.
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All animals with grade 0 conjunctivae (chemosis) score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - No effects on the cornea or iris were noted at any reading. In all animals, a slight conjunctival redness (score 1) was noted 1 hour after instillation but this redness had gone within 24 hours after application in all animals.
- Other effects:
- None
Any other information on results incl. tables
Table 1: Numerical scores awarded to the ocular reaction (Study# 71152)
Animal No. |
Region of eye |
Observation point |
Positive (+) or Negative (-) |
||||||
1 hour |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 7 |
||||
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Negative (-) |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|||
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Negative (-) |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Negative (-) |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Test substance produced transient irritation to the conjunctivae at 2.5% dilution
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- A 2.5% aqueous solution of 4-amino-2-hydroxy toluene showed transient irritation to rabbit conjunctivae under the test conditions, based on the slight and reversible effects noted 1 hour post instillation in this study.
Although the test procedure did not follow currently accepted guidelines and the purity of the test substance is unknown, the results can be accepted as being indicative of the irritant potential of a 2.5% dilution of the test substance. - Executive summary:
The acute eye irritation potential of toxicity of 4-amino-2-hydroxy toluene was determined following Code of Federal Regulations, Title 16, Section 1500.42, test for eye irritants.
0.1 mL of a 2.5% solution of 4-amino-2-hydroxy toluene in 0.5% aqueous gum tragacanth containing 0.05% sodium sulphite, was introduced into the conjunctival sac of one eye each of 3 albino rabbits: the untreated eyes served as controls. 10 seconds after instillation of the test material, the eyes were washed with 50 mL (37°C) water. Both eyes were examined at 1 hour, and at Day 1, 2, 3, 4 and 7 post application and effects were scored according to the Draize scheme.
No effects on the cornea or iris were noted at any reading. In all animals, a slight conjunctival redness (score 1) was noted 1 hour after instillation but this redness was gone within 24 hours after application in all animals.
Based on the slight and reversible effects noted 1 hour post instillation in this rabbit study, a 2.5% aqueous solution of 4-amino-2-hydroxy toluene showed transient irritation to rabbit conjunctivae under the test conditions. Although the test procedure did not follow currently accepted guidelines and the purity of the test substance is unknown, the results can be accepted as being indicative of the irritant potential of a 2.5% dilution of the test substance.
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