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EC number: 203-401-0 | CAS number: 106-47-8
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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)
- Qualifier:
- according to guideline
- Guideline:
- other: Verordnung über gefährliche Stoffe (Gefahrstoffverordung-GefStoffV ) vom 26. August 1986 (BGB1. I S. 1470)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-chloroaniline
- EC Number:
- 203-401-0
- EC Name:
- 4-chloroaniline
- Cas Number:
- 106-47-8
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 4-chloroaniline
- Details on test material:
- - Name of test material (as cited in study report): p-chloranilin, DS
- Physical state: solid (crystalline light-brown product)
- Analytical purity: 99.5%
- Purity test date: 12.09.1990
- Product number/code: Hoe CG 0080 OD ZD00 0002
- Storage condition of test material: at 20°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hochst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.8-4.3 kg
- Housing: animals were housed in individual cages in full air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen, Altromin GmbH, Lage/Lippe, Germany, ad libitum plus hey (about 15 g daily)
- Water (e.g. ad libitum): deionized, chlorinated water from automatic drinking trough ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours per day
IN-LIFE DATES: From: 03.07.1990 To: 17.07.1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 7 days after the exposure
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Washing (if done): yes, with physiologic saline solution
- Time after start of exposure: at 24 hours after exposure, and at all the other time points. The washing was performed also when excretions were observed in the treated eyes and when the fluorescein test was performed on the cornea of the treated eyes.
SCORING SYSTEM: Draize score
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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 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: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 days
- Irritant / corrosive response data:
- At 1 and 24 hours post-exposure the conjunctiva of the animals showed the following effects: from a diffuse, carmine red colour to a diffuse, strong red colour and from a slight to clear swelling. 24 hours post exposure the iris of the animals was reddened and the cornea showed a diffuse opacity. 48 hours post-exposure an obvious hyperaemia of some vasculature of the conjunctiva and a diffuse carmine red colour of the conjunctiva were observed respectively. Two animals showed a slight swelling of the conjunctiva. Still at 72 hours post-exposure a marked hyperaemia of some vasculature of the conjunctiva was observed on two animals.
The appearance of the irritation was accompanied from a clear, colourless discharge. All irritation symptoms were reversible 7 days after the exposure.
Any other information on results incl. tables
Time endpoint after application |
24h |
48h |
72 h |
Mean (24-72 h) |
||||||
Animal number |
81 |
173 |
200 |
81 |
173 |
200 |
81 |
173 |
200 |
All animals |
Conjuctiva: Chemosis |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0.6 |
Conjuctiva: redness |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
1.7 |
Iris |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0.3 |
Corneal opacity |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0.3 |
Fluoresceintest |
2 |
3 |
2 |
|
|
|
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: no labeling required
- Remarks:
- Criteria used for interpretation of results: EU
- Executive summary:
Kreiling (Hoechst AG, 1990):
A eye irritation test was conducted on rabbits according to OECD guideline 404.
100 mg of 4-Chloranilin was applied in the conjunctival sac of the left eye of each rabbits. The observation of the eyes was performed 1, 24, 48, and 72 hours after the application of the test substance. At 1 and 24 hours post-exposure the conjunctiva of the animals showed the following effects: from a diffuse, carmine red colour to a diffuse, strong red colour and from a slight to clear swelling. 24 hours post exposure the iris of the animals was reddened and the cornea showed a diffuse opacity. 48 hours post-exposure an obvious hyperaemia of some vasculature of the conjunctiva and a diffuse carmine red colour of the conjunctiva were observed respectively. Two animals showed a slight swelling of the conjunctiva. Still at 72 hours post-exposure a marked hyperaemia of some vasculature of the conjunctiva was observed on two animals. The appearance of the irritation was accompanied by a clear, colourless discharge. All irritation symptoms were reversible 7 days after the exposure.
In relation to the the present study the 4-chloroaniline is consequently evaluated als slight irritant. However, according to the classification criteria of the guideline 83/467/EWG and of the regulation for hazardous substances no labeling is required for 4-chloroaniline.
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