2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

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 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

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

Test material information

Constituent 1

Reference substance name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

EC Number:

236-747-6

EC Name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

Cas Number:

13473-26-2

Molecular formula:

C20H4Br4Cl4O5

IUPAC Name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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	2^nd	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.