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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl malonate
EC Number:
203-597-8
EC Name:
Dimethyl malonate
Cas Number:
108-59-8
Molecular formula:
C5H8O4
IUPAC Name:
dimethyl malonate

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb: HM, SPF
Details on test animals or tissues and environmental conditions:
Weight at study initiation: 2 - 3 kg

Test system

Controls:
yes, concurrent no treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 0.33
Max. score:
0.33
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 0.67
Max. score:
0.67
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.67
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1.67
Max. score:
1.67
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1.33
Max. score:
1.33
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.33
Irritation parameter:
other: conjunctivae redness score
Basis:
animal #1
Time point:
other: 24,48,72 hours
Score:
2
Max. score:
2
Irritation parameter:
other: conjunctivae redness score
Basis:
animal #2
Time point:
other: 24,48,72 hours
Score:
2
Max. score:
2
Irritation parameter:
other: conjunctivae redness score
Basis:
animal #3
Time point:
other: 24,48,72 hours
Score:
2
Max. score:
2
Irritation parameter:
other: conjunctivae redness score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Irritation parameter:
other: conjunctivae chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 hours
Score:
>= 0 - <= 1.67
Max. score:
1.67
Irritation parameter:
other: conjunctivae chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 hours
Score:
>= 0 - <= 1.33
Max. score:
1.33
Irritation parameter:
other: conjunctivae chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 hours
Score:
>= 0 - <= 1.33
Max. score:
1.33
Irritation parameter:
other: conjunctivae chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 1.44
Irritant / corrosive response data:
1 h p.a.: Medium grade erythema of the conjunctivae and slight
corneal opacity as well as excretion of a white exsudate from
the treated eyes was observed in all 3 animals. 2 animals had
additionally a very slight edema, one a marked edema.
24 h p.a.: All 3 animals showed medium grade erythema and
marked edema of the conjunctivae, indications of an irritaiton
of the iris with intact pupil reaction. The cornea was
slightly opaque (in 2 animals the whole area was affected, in
1 animal about half of the area). Exsudation was still
observed in one animal.
48 h p.a.: The medium grade erythema was unchanged in all
animals, while edema was reduced in 2 animals. 2 animals still
showed iridal irritation while it was reduced in one animal.
In 2 animals corneal opacity had increased slightly.
Exsudation was still observed in one animal.
72 h p.a.: The medium grade erythema was unchanged in all
animals, while edema was reversed. Iridal irritation was still
observed in one animal. Slight corneal opacity was seen in 2animals (covering one and 3 quarts of
the surface
respectively) while in 1 animal corneal opacity wa still
unchanged.
6 d p.a.: Corneal and iris reactions were reversed completely
in all animals, very slight conjunctival irritation and
chemosis was observed in 2 animals.
8 d p.a.: All effects were reversible by day 8

Applicant's summary and conclusion

Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Cornea: turbidity
Iris: normal