Registration Dossier
Registration Dossier
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EC number: 695-022-6 | CAS number: 473278-76-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 June - 01 July 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 09 Oct 2017
- Deviations:
- yes
- Remarks:
- No use of analgesics.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-chloro-4-methanesulfonyl-3-{[(oxolan-2-yl)methoxy]methyl}benzoyl)cyclohexane-1,3-dione
- EC Number:
- 695-022-6
- Cas Number:
- 473278-76-1
- Molecular formula:
- C20 H23 Cl O7 S
- IUPAC Name:
- 2-(2-chloro-4-methanesulfonyl-3-{[(oxolan-2-yl)methoxy]methyl}benzoyl)cyclohexane-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV breeding establishment, Saint Mars d'Egrenne, France
- Age at study initiation: 9 -10 weeks
- Weight at study initiation: 3.1 - 3.2 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL - Amount applied: 0.1 mL
- Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- - Other observations: The application of the test substance did not induce colouring of the application site and did not interfere with grading of any eye lesion.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
| Rabbit # | Time [h] | conjunctivae | iris | cornea | |
| redness | swelling | ||||
| 1 | 1 | 0 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0 | 0 | 0 | 0 | |
| 2 | 1 | 1 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0 | 0 | 0 | 0 | |
| 3 | 1 | 1 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0 | 0 | 0 | 0 | |
| Time [h] | conjunctivae | iris | cornea | ||
| redness | swelling | ||||
| average score |
1 | 0.67 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| 24+48+72 | 0 | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. In this study, the test substance was not an eye irritant.
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