2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 7-21, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

EC Number:

424-190-3

EC Name:

2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

Cas Number:

105641-66-5

Molecular formula:

C53H26N8O17S4

IUPAC Name:

2,3-bis({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)-6-[4-({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)benzoyl]phenyl 5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalene-1-sulfonate

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3 kg
- Housing: singly
- Diet: ad libitum Altromin 2123 maintenance diet – rabbits and hay
- Water: deionized, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- 100 mg

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

The eyes were examined 1, 24, 48 and 72 houry after application of the test substance and after 7 days.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

From one hour up to 24 h the conjunctivae of the animals showed slight to obvious swellings with partial eversion of lids. Up to 72 h p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings were noted. After 7 days the irritations were reversible.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the study according to OECD Guideline 405 the test item is not irritating to the eyes.

Executive summary:

The test substance was tested for its potential to cause eye irritation in a study according to OECD Guideline 405. Three  New Zealand White rabbits were treated with a single application of 100 mg test item in one eye. Signs of irritation were scored according to Draize. The 24/48/72 hours mean scores for animal No. 1/2/3 are the following: cornea scores: 0/0/0; iris scores: 0/0/0; conjunctiva scores: 1.3/1/2; chemosis scores: 0.3/0.3/0.3. All findings were reversible within 7 days. Therefore, the test substance is not considered to be classified for eye irritation.