Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09-05-1977 - 31-05-1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
different scoring system
Qualifier:
equivalent or similar to
Guideline:
other: Modified Federal Hazardous Substances Labelling Act Method
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 weeks

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
at 15 min., 1, 2, and 3 days
Number of animals or in vitro replicates:
3
Details on study design:



TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal: 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.

Applicant's summary and conclusion

Interpretation of results:
other: Not an eye irritant
Remarks:
according to EU CLP (EC 1272/2008 and its amendments)
Conclusions:
The test substance is not eye irritating.
Executive summary:

The primary eye irritation potential of Cyclacet was investigated in a study similar to OECD Test Guideline 405 (Acute Eye Irritation / Corrosion). A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated. Mean chemosis, conjunctivae and iris scores at the 24, 48, and 72 hour time point were 0.33 in 1 animals and 0 in the other two animals. The effects seen in the one animal was reversible within one day. Corneal opacity scores were 0.67, 0.33, and 0 for the three animals respectively. The corneal opacity was absent within three days. It is concluded that Cyclacet is not an eye iritant.