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EC number: 203-403-1 | CAS number: 106-49-0
- 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:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- p-toluidine
- EC Number:
- 203-403-1
- EC Name:
- p-toluidine
- Cas Number:
- 106-49-0
- Molecular formula:
- C7H9N
- IUPAC Name:
- 4-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-toluidine
- Physical state: solid (crystalline form)
- Analytical purity: >99%
- Lot/batch No.: GGHA 405
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.9-4.1 kg
- Housing: animals were caged individually in air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°
- Humidity (%): 50 ± 29
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours, and 7, and 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline phisiological solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize score system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- One hour to 72 hours after exposure the conjunctivae of the animals showed slight to clear swellings with circa semiclosed lids and a clear hyperemiae of some vasculature until diffuse rich red colorations. The cornea of two animals showed diffuse areas of opacity. The iris of these animals was reddened. Additionally a clear and colourless discharge was observed.
From 24 hours after exposure the discharge had a white colour. Furthermore ablations of the conjunctivae and the nictitating membranes occurred to two animals 48 until 72 hours after the exposure. These animals also showed a white discolouration of the nictitating membranes.
Seven days after exposure the conjunctivae showed clear hyperemiae of some vasculature until diffuse carmine colours. One animal showed a slight swelling of the conjunctiva.
Fourteen days after exposure all animals were without irritations.
Any other information on results incl. tables
Time endpoint after application |
24h |
48h |
72h |
Average (24 -72 h ) |
Average (24 -72 h) |
Average (24 -72 h) | Average (24 -72h) all animals | ||||||
Animal number |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 | 2 | 3 | |
Conjuctival Chemosis |
2 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
1 |
1.3 | 1.7 | 1.7 | 1.6 |
Conjuctival redness |
3 |
2 |
3 |
2 |
2 |
3 |
1 |
1 |
2 |
2.0 | 1.7 | 2.7 | 2.1 |
Iris |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
0.0 | 1.0 | 1.0 | 0.7 |
Corneal opacity |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
1 |
0.0 | 1.0 | 1.0 | 0.7 |
Fluorescein test |
1 |
3 |
2 |
|
|
|
0 |
1 |
2 |
- | - | - | - |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information according to EU-GHS/CLP Criteria used for interpretation of results: EU
- Executive summary:
Hofmann (1986)
In order to test the eye irritation potential of p-toluidine, 3 animals were tested according OECD 405 guideline test.
About 24 hours before the start of the investigation the treated eyes of research animals were analyzed for eventual damage of the cornea, after the instillation of one drop of fluorescein-sodium solution (0.01%).
100 mg of p-toluidine was applied in the conjunctival sac of one eye of each of 3 rabbits.
The observation of the eyes was performed 1, 24, 48, and 72 hours after the application of the test substance.
In addition at time points 24, 72 hours, and 7 and 14 days after the instillation of one drop fluorescein-sodium solution (0.01%), the cornea was examined under UV light in order to determine eventual damage.
One hour to 72 hours after exposure the conjunctivae of the animals showed slight to clear swellings with circa semiclosed lids and a clear hyperemiae of some vasculature until diffuse rich red colorations. The cornea of two animals showed diffuse areas of opacity. The iris of these animals was reddened. Additionally a clear and colourless discharge was observed.
From 24 hours after exposure the discharge had a white colour. Furthermore ablations of the conjunctivae and the nictitating membranes occurred to two animals 48 until 72 hours after the exposure. These animals also showed a white discolouration of the nictitating membranes.
Seven days after exposure the conjunctivae showed clear hyperemiae of some vasculature until diffuse carmine colours. One animal showed a slight swelling of the conjunctiva. Fourteen days after exposure all animals were without irritations.
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