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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:
other: well performed OECD and GLP guideline study

Data source

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

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:
2'-methoxyacetoacetanilide
EC Number:
202-131-0
EC Name:
2'-methoxyacetoacetanilide
Cas Number:
92-15-9
Molecular formula:
C11H13NO3
IUPAC Name:
N-(2-methoxyphenyl)-3-oxobutanamide
Details on test material:
- Name of test material (as cited in study report): Acetessig-o-anisidid TTR

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
- No of animals: 3
- Labeling: numbered ear tag
- Weight: 3.3-3.8 kg
- Age: 3-5 months
- Air conditioned rooms, single cages
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Feed: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum, as well as about 15 g of hay per day
- Water: deionized, chlorinated water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye of each animal served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Exposure period: 24 h. After the exposure period the treated eye was rinsed with physiol. saline (37°C)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean of animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effects at any time
Irritation parameter:
iris score
Basis:
other: mean of animal # 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Reversibility:
other: initial slight effects were fully reversible within 24h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Reversibility:
other: initial effects were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
other: mean of animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: initial slight effects were fully reversible within 24h
Other effects:
One hour after application the conjunctivae showed slight up to discrete swelling and diffuse reddening. One animal showed reddening of the iris. In addition a clear, colorless efflux could be observed.
24 to 48 h after application two respectively one animals showed distinct injected conjunctivae blood vessels. One animal showed a positive fluorescein test. All signs of irritation were fully reversible within 72h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test, the test substance is not eye irritating.
Executive summary:

The test substance was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as control. 24 h after instillation eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Mean scores for all irritation parameters were below threshold values and were fully reversible within 72 h.

Based on the findings in this test, the test substance is not eye irritating.