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Diss Factsheets

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:
August 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
The study was performed on a similar substance to the registered substance and as such is considered to be sufficient to address the endpoint by read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test substance is applied to one eye of each of a group of rabbits (2 rabbits) by gently pulling the lower eyelid away from the eyeball and placing 10 microL in the sac so formed. Treated eyes are examined 24 hours after treatment and thereafter at specified daily intervals and are graded for corneal, conjunctival and irridial damage. Corneal thickness is also measured and corneal swelling is recorded if present.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-oxo-2-pentylcyclopentaneacetate
EC Number:
246-495-9
EC Name:
Methyl 3-oxo-2-pentylcyclopentaneacetate
Cas Number:
24851-98-7
Molecular formula:
C13H22O3
IUPAC Name:
Methyl 3-oxo-2-pentyl-1-cyclopentaneacetate
Specific details on test material used for the study:
Test material name (as stated in the report): Methyl Dihydrojasmonate (S15102-T01)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age: 8 weeks old
Weight: At least 1 Kg
with no spontaneous eyes lesions
The animals are housed individually in cages with wire-mesh floors and hace access to a certified pelleted commercial rabbit diet and tap water ad libitium.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
Group B_ undiluted (as supplied)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 microL (100% concentration)
Duration of treatment / exposure:
instillation
Observation period (in vivo):
1, 2, 3, 4, 7, 9, 11, 14, 16, 18 and 21 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1291 and 1292
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1291 and 1292
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1291 and 1292
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: 1291 and 1292
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Both eyes showed only a transient slight erythema of the conjunctivae. The corneas of both eyes were unaffected by the treament and remained entirely normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, Methyl Dihydrojasmonate (S15102-T01) does not show irritant effect to eyes, it does not met the criteria for Eye irritation classication according the CLP Regulation (EC) No. 1272/2008.
Executive summary:

Methyl Dihydrojasmonate is tested to demonstrate the eye irritation potential. Test substance is applied to one eye of each of a group of rabbits (2 rabbits) by gently pulling the lower eyelid away from the eyeball and placing 10 microL in the sac so formed. Treated eyes are examined 24 hours after treatment and thereafter at specified daily intervals and are graded for corneal, conjunctival and irridial damage. Both eyes showed only a transient slight erythema of the conjunctivae. The corneas of both eyes were unaffected by the treament and remained entirely normal.

Under the conditions of this test, Methyl Dihydrojasmonate (S15102-T01) does not show irritant effect to eyes, it does not met the criteria for classication according the CLP Regulation (EC) No. 1272/2008.