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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
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:
other: Test was conducted similar to OECD Test Guideline No. 405, but not under GLP Standards.
Justification for type of information:
The information is used to read across to Cyclacet Dihydro.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information is retrieved from read across infiormation.
Justification for type of information:
The information is based on the analogue Cyclacet. The justification is presented in the Endpoint summary and includes also skin irritation. The accompanying file is also attached there.
Reason / purpose for cross-reference:
read-across source
Number of animals or in vitro replicates:
3
Details on study design:



TOOL USED TO ASSESS SCORE: hand-slit lamp
Other effects / acceptance of results:
The information is retrieved from read across, therefore the in vitro results cannot be filled.
Irritation parameter:
cornea opacity score
Remarks:
swelling in %
Basis:
animal #1
Time point:
other: 1 day
Score:
45
Max. score:
45
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: swelling is in percentage
Irritation parameter:
cornea opacity score
Remarks:
swelling
Basis:
animal #2
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
swelling
Basis:
animal #3
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #1
Time point:
other: 1 day
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #2
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #3
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 day
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2-days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Cyclacet (in report Jasmacyclene Crude) 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.

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.

Interpretation of results:
other: not eye irritating
Remarks:
according to the EU CLP Regulation 1272/2008
Conclusions:
The substance is not an eye irritant.

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

Test material

1
Chemical structure
Reference substance name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
EC Number:
911-369-0
Molecular formula:
C12H16O2
IUPAC Name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 9 weeks

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

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
Remarks:
swelling in %
Basis:
animal #1
Time point:
other: 1 day
Score:
45
Max. score:
45
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: swelling is in percentage
Irritation parameter:
cornea opacity score
Remarks:
swelling
Basis:
animal #2
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
swelling
Basis:
animal #3
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #1
Time point:
other: 1 day
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #2
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: erythema
Basis:
animal #3
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 day
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2-days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 day
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Jasmacyclene Crude 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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
other: not an eye irritant
Remarks:
according to EU CLP (1272/2008 and its amendments)
Conclusions:
Cyclacet (in report Jasmacyclene Crude) is slightly irritant to eyes and may cause a stinging sensation if splashed into the eyes, but does not warrant classification and labelling).
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.

It is concluded that Cyclacet is slightly irritant to eyes and may cause a stinging sensation if splashed into the eyes. According to the Modified Federal Hazardous Substances Labelling Act Method a slight irritating potential of the test compound has been found. However, the findings result in absence of eye irritation.