Registration Dossier
Registration Dossier
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EC number: 204-501-7 | CAS number: 121-86-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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:
- 2-chloro-4-nitrotoluene
- EC Number:
- 204-501-7
- EC Name:
- 2-chloro-4-nitrotoluene
- Cas Number:
- 121-86-8
- Molecular formula:
- C7H6ClNO2
- IUPAC Name:
- 2-chloro-1-methyl-4-nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): 2-Chlor-4-nitrotoluol TTR
- Purity: > 98 %
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)
- Age at study initiation: approx. 3-5 months
- Weight at study initiation: 3.1-4.0 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one untreated eye of test animals served as control
- Amount / concentration applied:
- Amount: 0.1 g
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours post application. If no irritation indices were observed after 72 hours, the study was finished.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: rinsed 24 hours after instillation with tepid physiologic saline
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,2,3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score after 24, 48 and 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal: #1,2,3
- Time point:
- other: 1 hour
- Score:
- 0 - 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean score after 24, 48 and 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,2,3
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48 hours
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,2,3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: mean score after 24, 48 and 72 hours: 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,2,3
- Time point:
- other: 1 hour
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score after 24, 48 and 72 hours: 0.0
Any other information on results incl. tables
The fluorescein test performed after 24 and 72 hours revealed no effects on the cornea surface. One hour after instillation a clear ocular outflow was observed in 2/3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
2-Chlor-4-nitrotoluol TTR was not irritating to the eyes of rabbits according to OECD TG 405.
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