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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl malonate
EC Number:
203-305-9
EC Name:
Diethyl malonate
Cas Number:
105-53-3
Molecular formula:
C7H12O4
IUPAC Name:
diethyl malonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
at the start of the study the animals weghted 2.54-3.12 Kg and were approximately twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was wrintten with a black indelible marker-pen on the inner surface of the ear and on a cage label.

Test system

Vehicle:
not specified
Controls:
other: second eye
Amount / concentration applied:
On the day of the test each animal was held firmly but gently until quiet. Avolum of 0.1 mL of the test materia was instilled into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form cup into which the test material was dropped.
Duration of treatment / exposure:
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment
Observation period (in vivo):
Adverse ocular effects were noted at the72-hour observation and additioanl readings were made on days seven and fourteen.
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 5
Max. score:
5
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1h,24h,48h,72h,7d,14d,21d
Score:
>= 0 - <= 20
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 15
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 30
Max. score:
30
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 15
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 12
Max. score:
12
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 14
Max. score:
14
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 12
Max. score:
12
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 12
Max. score:
12
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 12
Max. score:
12
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 16
Max. score:
16
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal:
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 0 - <= 5
Max. score:
5
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1h,24h,48h, 72h, 7d, 14d
Score:
>= 4 - <= 25.8
Max. score:
25.8
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE (24, 48, 72 hours)
- Cornea: 0.6
- Iris: 0.8
- Conjuntivae (Redness): 1.7
- Conjuntivae (Chemosis): 1.3
- Overall irritation score: (Draize score) 25.8 of 110

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test material diethylmalonate was found to be a moderate irritant to the rabbit eye. The other reactions produced were considered to be reversible.