Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report

Data source

Reference

Reference Type:

other: Secondary Literature

Title:

OPINION ON test chemical

Author:

Scientific Committee on Consumer Safety (SCCS)

Year:

2010

Bibliographic source:

Scientific Committee, european commision

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Primary eye irritation potency was evaluated for the test material in three male rabbits.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

EC Number:

240-474-8

EC Name:

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

Cas Number:

16423-68-0

Molecular formula:

C20H8I4O5.2Na

IUPAC Name:

disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Erythrosine
- Molecular formula : C20H6I4Na2O5
- Molecular weight : 879.86 g/mol
-Substance type- Organic
- Physical state: Solid (powder)

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

5 minutes

Observation period (in vivo):

12, 24, 48, and 72 hrs

Number of animals or in vitro replicates:

3 male animals

Details on study design:

TEST SITE
- Area of exposure: lower conjunctival sac of the right eye
- % coverage: Not applicable
- Type of wrap if used: Not applicable

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with 300 ml distilled water
- Time after start of exposure: 12, 24, 48, and 72 hrs after treatment

SCORING SYSTEM: cornea, iris and conjunctival mucosa parameters.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 12, 24, 48, and 72 hrs

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No adverse ocular reactions was observed.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test chemical did not cause adverse ocular reactions at 12, 24, 48, and 72 hrs after treatment. Hence the test chemical was considered as not irritating to the eyes of treated rabbits

Executive summary:

Primary eye irritation potency was evaluated for the test material in three male rabbits. About 100 mg erythrosine was instilled into the lower conjunctival sac of the right eye. The left eyes of the animals served as controls. 5 minutes after application, the treated eye was washed with 300 ml distilled water and the cornea, iris and conjunctival mucosa of treated eyes were investigated at 12, 24, 48, and 72 hrs after treatment. The test chemical did not cause adverse ocular reactions at 12, 24, 48, and 72 hrs after treatment. Hence the test chemical was considered as not irritating to the eyes of treated rabbits.