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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:
2003-05-05 to 2003-05-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
EC Number:
228-528-9
EC Name:
Dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
Cas Number:
6289-46-9
Molecular formula:
C10H12O6
IUPAC Name:
1,4-dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
Details on test material:
- Name of test material (as cited in study report): DIMETHYLSUCCINYLOSUCCINATE

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Yes, concurrent no treatment. The left eyes remained untreated and served as a control.
Amount / concentration applied:
Approximate equivalent of 0.1 mL, weighed amounts of individual doses were 92, 85 and 86 mg.
Duration of treatment / exposure:
Without rinsing after instillatin.
Observation period (in vivo):
Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a.
Number of animals or in vitro replicates:
3
Details on study design:
The approximate equivalent of 0.1 mL of the test substance was administered per animal into
the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs
for instillation. The eyes were held closed for about one second to prevent a loss of test
substance.

Firstly, the test substance was given to one animal. As no evidence for a serious damage to
the eye of this animal was found during the initial 72 hour observation period (no corrosive
effect), the test substance was administered to the other two animals subsequently.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean of 24, 48 and 72h for Animal #: 11/12/13
Corneae scores: 0.0/0.0/0.0
Irises scores: 0.0/0.0/0.0
Conjunctivae Redness scores: 0.0/0.0/0.0
Conjunctivae Chemosis scores: 0.0/0.0/0.0

Slight effects (1h) were fully reversible wihin 24h.

The untreated eyes ("control eyes") were normal at each observation time.
Other effects:
No other effects were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
DIMETHYLSUCCINYLOSUCCINATE is not irritant to eyes.
Executive summary:

The aim of this study was to investigate possible irritating or corrosive effects of the test substance as is following a single administration into a conjunctival sac of rabbits.

Methods and investigations were performed in conformance with the OECD-Guideline 405.

The approximate equivalent of 0.1 mL of "DIMETHYLSUCCINYLOSUCCINATE" was instilled into the conjunctival sac of one eye of each of 3 rabbits.

Investigations included: Body weights: at the start and at the termination of the test. General signs of toxicity: once daily. Eye examinations: 1, 24, 48 and 72 h after the administration (p.a.) of the test substance.

No other than ocular lesions were noted.

Corneae and irises: Not affected. Conjunctivae, redness: In 1/3 animals some injected blood vessels were observed only 1 h p.a.. Conjunctivae, chemosis: In 1/3 animals very slight swelling was observed only 1 h p.a..

Based on this findings DIMETHYLSUCCINYLOSUCCINATE is not irritant to eyes.