2-amino-4,6-dinitrophenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

OPINION ON Picramic acid and sodium picramate COLIPA n° B28

Author:

Scientific Committee on Consumer Safety

Year:

2012

Bibliographic source:

Scientific Committee on Consumer Safety, (SCCS) 18 September 2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

To assess the toxic effect of Picramic acid in rabbit by ocular application.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-4,6-dinitrophenol

EC Number:

202-544-6

EC Name:

2-amino-4,6-dinitrophenol

Cas Number:

96-91-3

Molecular formula:

C6H5N3O5

IUPAC Name:

2-amino-4,6-dinitrophenol

Test material form:

other: Dark red needles

Details on test material:

- Name of test material (as cited in study report): picramic acid
- Molecular formula (if other than submission substance): C6H5N3O5
- Molecular weight (if other than submission substance): 199.12 g/mol
- Substance type: Organic
- Physical state: solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

other: Distilled water containing 0.05% sodium sulfite, buffered to pH 7

Controls:

not specified

Amount / concentration applied:

2.5% aqueous solution

Duration of treatment / exposure:

10 sec

Observation period (in vivo):

Up to 7 days.

Number of animals or in vitro replicates:

3

Details on study design:

TEST SITE
- Area of exposure: 0.1 ml of 2.5% aqueous solution of the test substance was instilled into the conjunctival sac of one eye of each animal
- % coverage: No data available.
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): These eyes were rinsed with 20 ml distilled water after 10 seconds.
- Time after start of exposure:

SCORING SYSTEM:

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 7 days

Reversibility:

not specified

Remarks on result:

other: there was conjunctival redness persisting to 4 days, and up to 7 days in one animal.

Applicant's summary and conclusion

Conclusions:

Under the condition of the test, a 2.5% aqueous solution of picramic acid was irritant to rabbit eyes.

Executive summary:

In acute Eye irritation test of Picramic acid was determined in rabbit eye for over 7 days. A 0.1 ml of 2.5% aqueous solution of the test substance was instilled into the conjunctival sac of one eye of each animal. These eyes were rinsed with 20 ml distilled water after 10 seconds. In all 3 animals, there was conjunctival redness persisting to 4 days, and up to 7 days in one animal. Therefore, Picramic acid was found to be irritant to rabbit eyes.