methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

Eye irritation

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: This study has been performed in accordance with OECD guideline No.:405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

EC Number:

810-021-4

Cas Number:

111304-31-5

Molecular formula:

C12H11NO5

IUPAC Name:

methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

Test material form:

solid: crystalline

Details on test material:

Name: Niliden
Cas no.: 111304-31-5
Batch no.: ND-78
Date of analysis: October 2014
Re-test date: October 2015
Storage: In the refrigerator (2-8°C)
Description: a white to pale yellow crystalline substance
Purity by HPLC: 99,6%
pH value: 5-6

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Number of animals: 1 male
Age of animals: adult rabbit, 11 weeks old
Body weight at the beginning of the study: 2786 g
Body weight at the end of the study: 3216 g
Housing: Animal was housed individually in metal cage
Light: 12 hours daily, from 6:00 a.m. to 6:00 p.m.
Temperature: 20±3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges / hour by central air-conditioning system

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0,1 g of test item was used for the study in undiluted form.

Duration of treatment / exposure:

The test item was instilled into the conjunctival sac of the left eye of animal. The eye of the test animal was not washed out 24 hour after test item application.

Observation period (in vivo):

The eyes were examined at 1, 24, 48, 72 hours after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility.

Number of animals or in vitro replicates:

1

Details on study design:

The acute eye irritation study with test item Niliden was performed in a New Zealand White rabbit. The initial test was performed only; because of severe conjunctival irritation sign occured 24 hours after the treatment.

Results and discussion

In vivo

Results

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24,48,72

Score:

4

Reversibility:

fully reversible within: 2 weeks

Irritant / corrosive response data:

1 hour after the single application of test item into the eye of the rabbit, moderate redness, moderate to severe chemosis and severe discharge occured.
24 hours after treatment severe chemosis and discharge were recorded. Redness of conjunctivae, corneal and iris alterations could not be observed due to the swelling the lids were completely closed.
1 week after treatment slight redness, slight to moderate chemosis and slight discharge were recorded.
2 weeks after the treatment animal was free of symptoms, so the study was finished.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to Regulation (EC) No. 1272/2008, the test item should be classified into "Category 2 (reversible effects on the eye/irritating to eyes)" on the basis of conjunctivae irritation sign as chemosis.
However, it is to be noted that the test item caused severe conjunctivae irritation sign as chemosis in 24, 48 and 72 hours after the treatment, so the redness, cornea opacity and iris irritation could not be scored.