Registration Dossier
Registration Dossier
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EC number: 230-086-7 | CAS number: 6940-53-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-02-18 to 1986-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented guideline study (EU & OECD) with GLP
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP compliance statement attached to full study report.
Test material
- Reference substance name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
- EC Number:
- 230-086-7
- EC Name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
- Cas Number:
- 6940-53-0
- Molecular formula:
- C8H8ClNO4
- IUPAC Name:
- 1-chloro-2,5-dimethoxy-4-nitrobenzene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- Identification: numbered earmarks
- Weight: 2.3 - 2.5 kg
- Age: approx. 3 - 5 months
- Housing: in air conditioned rooms in single cages
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting conditions: 12 hours daily
- Diet: Altromin 2123, ad libitum, hay: approx 15 g daily
- Water: deionised, chlorinated water from automatic dispensers, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- - Amount applied: 100 mg of test substance
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 1, 24, 48, 72 hrs
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Washing: 24 hrs after application of test substance. At all other examinations at which discharge was observed or cornea was examined.
- Washing with physiol. saline solution (37 °C)
- Cornea examined for possible damages using fluorescin-sodium solution (0.01 %) and under ultraviolett light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- 1 hour to 24 hours p.a. all animals showed slight clear discharges. Conjunctivae were slightly to obviously swollen and crimsonred. The iris of all animals was reddish. One animal showed 24 hours p.a. scattered opacity in the cornea. 48 hrs only one animal had some clearly visible blood vessels in the eyes. 72 hrs p.a. all animals were clear of any signs of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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