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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
Ca. 50 mg of the test substance KAC 4196 was applied into the conjunctival sac of 2 rabbits. The evaluation eas done 1 h, 24 h, 2 d, 3 d, 4 d, 7 d after instillation. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
EC Number:
229-542-8
EC Name:
3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane
Cas Number:
6600-31-3
Molecular formula:
C19H28O4
IUPAC Name:
3,9-bis(cyclohex-3-en-1-yl)-2,4,8,10-tetraoxaspiro[5.5]undecane
Test material form:
other: solid
Details on test material:
Test substance: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no applicable - score = 0 at any time point

Any other information on results incl. tables

One hour and 24 hours after application of the test substance a slight reddening and swelling was observed.These findings are caused vy mechanical irritation of the eyes by the test substance. The reddening and swelling were reversible during the observation period of 7 days. cornea and iris revealed no findings.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Ca. 50 mg of the test substance KAC 4196 was applied into the conjunctival sac of 2 rabbits. The evaluation eas done 1 h, 24 h, 2 d, 3 d, 4 d, 7 d after instillation. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.

The mean cormeal opacity score after 24, 48, and 72 hours was 0, the iris score = 0, the redness conjunctivae score = 0.3 and the chemosis conjunctivae score = 0.