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EC number: 202-446-3 | CAS number: 95-74-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-chloro-p-toluidine
- EC Number:
- 202-446-3
- EC Name:
- 3-chloro-p-toluidine
- Cas Number:
- 95-74-9
- Molecular formula:
- C7H8ClN
- IUPAC Name:
- 3-chloro-4-methylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: 3-chloro-p-toluidine; purity: at least 99 %; impurities: max. 1 % p-toluidine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each rabbit served as control
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 7 days after application of test substance the eyes were examined
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening of conjunctiva
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- swelling of conjunctivae
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- One hour after application of test substance clearly defined swelling of the conjunctiva was observed. Some bloodvessels showed a defined hyperemia. The iris was reddened in two animals. On the cornea diffuse opacity regions were seen. These findings came along with white-brownish defluxion.
24 up to 72 Hours after application of test substance slight to clear swelling of conjunctiva was observed. The conjunctiva showed a considerable hyperemia up to diffuse strong reddening. The iris of all animals was reddened. On the cornea diffuse opacoty regions were seen. In two animals bleeding in the conjunctiva were observed. These findings came along with a white defluxion.
7 days after application of the test substance the appearance of irritation was reversible.
Any other information on results incl. tables
Results:
Time post application | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | ||||||||||
Animal Number | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Swelling of conjunctiva | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Reddening of conjunctiva | 1 | 1 | 1 | 2 | 1 | 2 | 3 | 3 | 3 | 3 | 2 | 3 | 0 | 0 | 0 |
Iris | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Corneal turbidity | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Fluorescein-Test | 2 | 3 | 2 | 3 | 1 | 4 | 0 | 0 | 0 | ||||||
Eye defluxion | |||||||||||||||
-white-brownish | x | x | x | ||||||||||||
-white | x | x | x | x | x | x | x | ||||||||
Bloody Conjunctiva | x | x | x | x | x | x | x | x | x | x | x | ||||
Reddened Iris | x | x | x | x | x | x | x | x | x | x | x |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Executive summary:
In an eye irritation study according to OECD TG 405 the test substance was tested in the eyes of 3 New Zealand White rabbits.
24 hours before application of test substance, the eyes of the test rabbits were examined to detect posible damages on the cornea. Only animals showing no findings were used. 100 mg test substance was applied in a single dose into the conjunctival sac of the left eye of the test animals, the other eye served as control. 1, 24, 48, 72 hours and 7 days after application of test substance the eyes were examined.
One hour after application of test substance clearly defined swelling of the conjunctiva was observed. Some bloodvessels showed a defined hyperemia. The iris was reddened in two animals. On the cornea diffuse opacity regions were seen. These findings came along with white-brownish defluxion.
24 up to 72 Hours after application of test substance slight to clear swelling of conjunctiva was observed. The conjunctiva showed a considerable hyperemia up to diffuse strong reddening. The iris of all animals was reddened. On the cornea diffuse opacoty regions were seen. In two animals bleeding in the conjunctiva were observed. These findings came along with a white defluxion.
7 days after application of the test substance the appearance of irritation was reversible.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Irrit. 2 ( H319: Causes serious eye irritation.) is justified.
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