Registration Dossier
Registration Dossier
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EC number: 604-247-0 | CAS number: 141719-29-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13-17 October 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- [2-(4-chlorobutyl)cyclopenta-2,4-dien-1-yl](cyclopenta-2,4-dien-1-yl)iron
- EC Number:
- 604-247-0
- Cas Number:
- 141719-29-1
- Molecular formula:
- C14H17ClFe
- IUPAC Name:
- [2-(4-chlorobutyl)cyclopenta-2,4-dien-1-yl](cyclopenta-2,4-dien-1-yl)iron
- Test material form:
- liquid
- Details on test material:
- Appearence: brown-red liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
SNPE / LD 2332
- Appearence: brown-red liquid
- Name of test item: CL 1038
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
refrigerated under nitrogen
- Solubility and stability of the test substance in the solvent/vehicle:
soluble in common solvents (acetone, hexane, chlorinated solvents)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine, France
- Weight at study initiation: 2.4 ± 0.2 kg
- Housing: Individually housed in polystyrene cages
- Diet (e.g. ad libitum): 112 C pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 7 days
- prophylactic treatment during 5 days of the acclimatation period: mucoxid at 140 mg/kg bw/day (Veda-Cogla) added to drinking water
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: No
SCORING SYSTEM: OECD guideline 405
TOOL USED TO ASSESS SCORE: - For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution. This evaluation was performed on Day 2 and repeated thereafter whenever necessary.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight chemosis and redness of conjunctive were observed 1 h after administration. Slight redness was osberved in one animal at 24 h. No more reaction was recorded at 48 and 72 h.
- Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of test item in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 h after instillation and graded according to the OECD guideline 405. For the evaluation of corneal opacification, the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution. This evaluation was performed at 24 h post-instillation and repeated thereafter whenever necessary.
Slight chemosis and redness of conjunctive were observed 1 h after administration. Slight redness was osberved in one animal at 24 h. No more reaction was recorded at 48 and 72 h.
Under the test conditions, test item is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) N° (1272-2008) and GHS.
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