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Toxicological information

Eye irritation

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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: refer below principle
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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).
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
not specified
Remarks on result:
other: no additional details mentioned
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
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