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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 assessment reports

Data source

Reference
Reference Type:
other: Secondary source
Title:
Eye irritation potential of test chemical
Author:
Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)
Year:
2004
Bibliographic source:
, European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP), 2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the ocular irritation potential of test chemical according to OECD 405 Guideline.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Acid Red 92
- Molecular formula: C20H2Br4Cl4O5Na2
- Molecular weight : 829.66 g/mol
- Substance type: Organic
- Physical state: Red powder
- Purity: 94.0 - 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Sex: Male and female

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Duration of treatment: 17 days
Duration of exposure: No data available
Observation period (in vivo):
1, 24, 48 and 72 hours, as well as 7 and 10, 14 and 17 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3 animals (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: Eye
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: Corneal opacity, iris, redness and chemosis of the conjunctivae

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 1 and 2
Time point:
other: 24-72 hr
Score:
0
Reversibility:
fully reversible within: 17 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
other: 24-72 hr
Score:
0.1
Reversibility:
fully reversible within: 17 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3
Time point:
other: 24-72 hr
Score:
0
Reversibility:
fully reversible within: 17 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1,2 and 3
Time point:
other: 24-72 hr
Score:
2
Reversibility:
fully reversible within: 17 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1,2 and 3
Time point:
other: 24-72hr
Score:
1.3
Reversibility:
fully reversible within: 17 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and
chemosis. A slight corneal opacity, affecting up to the whole area of the cornea, was also apparent in one animal from 24 hours to 10 days after treatment, A light to marked red staining
was also observed in the treated eye of all animals during the first 7 days after treatment.All ocular effects were reversible and were no longer evident 17 days after treatment
Other effects:
No corrosion was observed at any of the measuring intervals.

Any other information on results incl. tables

The individual mean scores were as follows:

Sr no

Parameter 0bserved for 24h,48h and 72h

1st

2nd

3rd

animal

1

cornea opacity

0.0

0.0

0.1

2

iris

0.0

0.0

0.0

3

conjunctiva redness

2.0

2.0

2.0

4

conjunctiva chemosis

1.3

1.3

1.3

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. A light to marked red staining was also observed in the treated eye of all animals during the first 7 days after treatment. All ocular effects were reversible and were no longer evident 17 days after treatment. The test chemical did not induce significant or irreversible damage to the rabbit eyes.Hence, test chemical can be considered not irritating to rabbit eyes.
Executive summary:

Primary eye irritation study was conducted on male and female New Zealand Albino rabbits to evaluate the irritating nature of the test material.

100 mg/0.1g of the test compound was instilled into one eye each of three young adult rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 10, 14 and 17 days after test item application.The instillation of the test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. A slight corneal opacity, affecting up to the whole area of the cornea, was also apparent in one animal from 24 hours to 10 days after treatment, A light to marked red staining was also observed in the treated eye of all animals during the first 7 days after treatment. All ocular effects were reversible and were no longer evident 17 days after treatment. No abnormal findings were observed in the iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. Test chemical did not induce significant or irreversible damage to the rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.