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EC number: 210-431-8 | CAS number: 615-50-9
- 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, not enough details to warrant Klimisch rating 1
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: The Code of Federal Regulations, Title 16, Section 1500.42 (Test for eye irritants)
- Deviations:
- yes
- Remarks:
- only three rabbits were used against six as recommended by guideline. Eyes were washed 10 sec after instillation of test substance (eyes can be washed after 24 h reading as per the guideline)
- GLP compliance:
- no
- Remarks:
- (pre-dates GLP)
Test material
- Reference substance name:
- 2-methyl-p-phenylenediamine
- EC Number:
- 202-442-1
- EC Name:
- 2-methyl-p-phenylenediamine
- Cas Number:
- 95-70-5
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 2-methylbenzene-1,4-diamine
- Reference substance name:
- 2-methyl-1,4-benzenediamine
- IUPAC Name:
- 2-methyl-1,4-benzenediamine
- Details on test material:
- - Name of test material: Toulene-2, 5 -diamine
- Molecular formula (if other than submission substance): Not reported
- Molecular weight (if other than submission substance): Not reported
- Substance type: Pure active substance
- Physical state: Not reported - Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Details on test animals & environmental conditions are not provided in the report.
Test system
- Vehicle:
- water
- Remarks:
- (containing 0.05% sodium sulphite (pH 7.0))
- Controls:
- other: Additional control animals are not required. Eye which did not receive any test substance served as control
- Amount / concentration applied:
- - Concentration: 2.5 % w/v
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 10 sec
- Observation period (in vivo):
- 1 h and once daily for Day 1, 2, 3, 4 and Day 7
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were washed with 50 mL of lukewarm (37°C) water 10 seconds after instillation of the test substance.
- Time after start of exposure: 10 Sec.
SCORING SYSTEM:
U.S. Department of Health, Education and Welfare. Food and Drug Administration Washington. D.C. 20204. “The illustrated Guide for Grading Eye Irritation by Hazardous Substances"
CorneaNo 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 those 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
Conjunctivae
Redness: (Refers to palpobral 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 figure indicate lowest grades s considered positive under Title 16, Section 15100.42 of the Code of federal Regulations.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Not reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- 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:
- 3
- Reversibility:
- not specified
- 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:
- 3
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- 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
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: Numerical scores awarded to the ocular reactions elicited by toluene-2,5-diamine (study # 71168)
Animal No. |
Region of eye |
1h |
Day |
Positive (+) or Negative (-) |
||||
1 |
2 |
3 |
4 |
7 |
||||
1 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
1 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
2 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
3 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
1 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
- None of the animals gave a "positive" reaction.
- Mild conjunctival inflammation only was observed in two animals on days one and three respectively.
- The third animal did not show any observable response to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Under the conditions of this test, a 2.5% toluene-2,5-diamine solution caused slight irritation to rabbit eyes.
- Executive summary:
The acute eye irritation of Toulene-1,5-Diamine on rabbit eye was determined following procedure described by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
The study was designed to evaluate the irritant effect of 2.5% w/v solution of Toulene-2,5-diamine (prepared as aqueous solution containing 0.05% sodium sulphite (pH 7.0)) to the rabbit eye
3 rabbits were instilled with 2.5% w/v solution of test substance (containing 0.05% sodium sulphite (pH - 7.0) into one eye. The untreated eye served as control. The eyes were washed with 50 mL lukewarm water (37°C) 10 sec after instillation of the test substance. Animals were examined for ocular reaction at 1 h, Day 1, 2, 3, 4 and 7.
None of the animals gave positive reaction. Mild conjunctival inflammation was observed in 2 animals (score 1) on Days 1 and 3 respectively.
Under the conditions of this test, a 2.5% toluene-2,5-diamine solution caused slight irritation to rabbit eyes.
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