2-nitrophenyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

yes

Principles of method if other than guideline:

Change of technique application of the test substance – the open-chamber method was used. The test substance suspension (20% concentration) was applied in quantities enough to completely cover the cornea. This change is deviation from study plan and had no impact on the results of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, 2-nitrophenyl ester

IUPAC Name:

Acetic acid, 2-nitrophenyl ester

Constituent 2

Reference substance name:

2-nitrophenyl acetate

EC Number:

210-233-1

EC Name:

2-nitrophenyl acetate

Cas Number:

610-69-5

Molecular formula:

C8H7NO4

IUPAC Name:

2-nitrophenyl acetate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): 2-Nitrophenyl Acetate

- Physical state: solid light yellow
- Analytical purity: 95 % w/w

- Impurities (identity and concentrations):
Phenol <5.0 % (w/w)
2,4-dinitrophenol <5.0 % (w/w)
2,6-dinitrophenol <5.0 % (w/w)
Acetic acid <1.0 % (w/w)
Water <5.0 % (w/w)
2-nitrophenol <5.0 % (w/w)

- Lot/batch No.: 201408
- Expiration date of the lot/batch: unlisted

- Storage condition of test material: The test substance will be stored in dry room in dark in
closed container at the room temperature

Test animals / tissue source

Species:

other: bovine eyes

Details on test animals or tissues and environmental conditions:

Exposed group (test substance) - 3 corneas (No. 11, 12, 14)
Positive control group (20% Imidazole) – 3 corneas (No. 3, 7, 8)
Negative control group (0.9% NaCl) –3 corneas (No. 2, 5, 6)

Test system

Duration of treatment / exposure:

4 hours

Results and discussion

In vivo

Results

Irritation parameter:

other: In Vitro Irritancy Score (IVIS)

Basis:

mean

Score:

78.16

Remarks on result:

other: Limit value: IVIS ≥ 55.1

Irritant / corrosive response data:

The In Vitro Irritancy Score (IVIS) was computed according the following formula:
IVIS = mean opacity value + (15 x mean permeability OD490 value)

Any other information on results incl. tables

Group	IVIS
Calculation	Result
NC(0.9% NaCl)	1.33 + 15 x 0.021	1.65
PC(20% Imidazole)	59.33 + 15 x 1.952	88.61
EXP(2-Nitrophenyl Acetate)	78.67 + 15 x (- 0.004)	78.61

Note: NC- negative control, PC- positive control, EXP – test substance application form

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The In Vitro Irritancy Score (IVIS) for the test substance was 78.61.

Executive summary:

This score is higher than the limit value of IVIS (55.1), which means that 2-Nitrophenyl Acetate was identified as a corrosive or severe irritant.