Registration Dossier
Registration Dossier
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EC number: 427-230-8 | CAS number: 5571-36-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 67/548/EEC, B.5 OECD Guideline no. 405: Acute Eye Irritation/Corrosion
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 427-230-8
- EC Name:
- -
- Cas Number:
- 5571-36-8
- Molecular formula:
- C20H26O3
- IUPAC Name:
- (3bS,11aS)-11a-methyl-1,2,3,3a,3b,4,5,6,8,9,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolan]-1-one
Constituent 1
Test animals / tissue source
- Species:
- other: Albino rabbit, New Zealand White (SPF-Quality)
Test system
- Amount / concentration applied:
- CA 70.9 MG
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Score:
- 1
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 3 days
- Other effects:
- Instillation of approximately 71 mg of ethylene deltenone (a
volume of appr. 0.1 ml) into one eye of three rabbits
resulted in effects on the iris and conjunctivae. iridic
irritation grade 1 was observed in two animals, 1 hour
after instillation only. The irritation of the conjunctivae
consisted of redness, chemosis and discharge and had
completely resolved within 48 hours in two animals and
within 72 hours in the third animal.
No corneal opacity was observed, and treatment of the eyes
with 2% fluorescein, 24 hours after test substance
instillation revealed no corneal epithelial damage in any
of the animals.
There was no evidence of ocular corrosion.
Remnants of the test substance were present in the eyes of
all animals on day 1.
No symptoms of systemic toxicity were observed in the
animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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