Registration Dossier
Registration Dossier
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EC number: 607-988-8 | CAS number: 2668-75-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
Test material
- Reference substance name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
- EC Number:
- 607-988-8
- Cas Number:
- 2668-75-9
- Molecular formula:
- C23 H28 O4
- IUPAC Name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
Constituent 1
- Specific details on test material used for the study:
- Chemical name: 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
ZK no.: 5560
Batch no.: 25031900
CAS no.: 002668-75-9
Purity: >77% (according to certificate of analysis no.: 92/8145, dated 24 Nov. 95 and re-analysis report 976014, dated 17.07.97)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- other: The left eye, which remained untreated, served as control.
- Duration of treatment / exposure:
- test substance remained in the eye - eye was not rinsed
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
A single application of 0.1 ml undiluted test substance into the conjunctival sac led to slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the eye.
- Executive summary:
The single applictaion of 0.1 ml undiluted test substance into the eye of 4 rabbits results in slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings. The scores relevant for classification according to Regulation (EC) No 1272/2008 were for the time-points 24, 48 and 72 hours 0 for cornea, iris and chemosis and 0.7 at maximum for conjunctiva/redness.
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