Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assesment reports

Data source

Reference

Reference Type:

secondary source

Title:

OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52

Author:

THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP)

Year:

2004

Bibliographic source:

THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP) /0803/ 23 April 2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the irritation effects of test material Acid Red 52 on rabbit eyes.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt

EC Number:

222-529-8

EC Name:

Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt

Cas Number:

3520-42-1

Molecular formula:

C27H30N2O7S2.Na

IUPAC Name:

sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate; 2-(3-diethylamino-6-diethylazaniumylidene-xanthen-9-yl)-5-sulfo-benzenesulfonate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):Acid Red 52
- Molecular formula : C27H30N2O7S2.Na
- Molecular weight : 580.6551 g/mol
- Substance type:Organic
Physical State: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report):sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate
- Common Name: Acid Red 52
- Molecular formula : C27H29N2NaO7S2
- Molecular weight : 580.7 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye acted as control

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

TEST SITE
Area of exposure: Conjunctival sac of the left eye
% coverage: Not applicable
Type of wrap if used: Not applicable

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours all eyes were rinsed with physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Scoring of irritation was performed 1, 7, 24, 48 and 72 hours after application with a magnifying glass.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Reversibility:

not specified

Remarks on result:

other: Because of colour interference, an exact judgement was not possible in the area of the cornea (1 and 7 hours after post application).

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Reversibility:

not specified

Remarks on result:

other: no additional details mentioned

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 72 hours

Score:

0.67

Reversibility:

not specified

Remarks on result:

other: no additional details mentioned

Results 4

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

mean

Time point:

other: 72 hours

Score:

0.06

Reversibility:

not specified

Remarks on result:

other: no additional details mentioned

Irritant / corrosive response data:

Because of color interference, exact reading was not recorded for corneal opacity in rabbits

Any other information on results incl. tables

Table 1: Overall Irritation Score

Irritation parameter	Mean score after 72 hours
Cornea opacity	0.00
Iris	0.00
Conjunctiva redness	0.67
Conjunctiva chemosis	0.06

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

An eye irritation study was carried out on Himalayan albino rabbits to assess the irritation potency of Acid Red 52. Because of colour interference, an exact judgement was not possible in the area of the cornea (1 and 7 hours after post application). The overall irritation score after 72 hours was as follows: Cornea = 0.00, iris = 0.00 , conjunctiva redness = 0.67, conjunctiva chemosis = 0.06
Hence it can be considered that Acid Red 52 was not irritating to rabbit eyes

Executive summary:

An eye irritation study was carried out on Himalayan albino rabbits to assess the irritation potency of Acid Red 52.

0.1 g of Acid Red 52 was instilled into the conjunctival sac of the left eye of six Albino-Himalaya rabbits. The right eye remained untreated and served as reference control. Scoring of irritation was performed 1, 7, 24, 48 and 72 hours after application with a magnifying glass. After 24 hours all eyes were rinsed with physiological saline.Because of colour interference, an exact judgement was not possible in the area of the cornea (1 and 7 hours after post application).

The overall irritation score after 72 hours was as follows: Cornea = 0.00, iris = 0.00 , conjunctiva redness = 0.67, conjunctiva chemosis = 0.06.

Hence it can be considered that Acid Red 52 was not irritating to rabbit eyes