Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate

EC Number:

282-850-4

EC Name:

Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate

Cas Number:

84434-51-5

Molecular formula:

C40H30Cl4N14O20S6.6Na

IUPAC Name:

hexasodium 6,13-dichloro-3,10-bis({[2-({4-chloro-6-[(2,4-disulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)ethyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate

Test material form:

other: presscake

Details on test material:

Reactive Blue 198

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
-Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater, Manchester, UK
-Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: 2.14-2.71Kg
- Housing: individually in satinised aluminium sheet cages
- Diet: Labsure CR6 Rabbit Diet ad libidum
- Water: via an automatic system ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature: 16-20°C
- Humidity: 43-80 %
- Photoperiod: 12 hours cycle dark/lights maintained at a temperature

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approx. 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 1

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of Reactive Blue 198 for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eyes.

Executive summary:

100 mg Reactive Blue 198 was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

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

Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:

Opacity of cornea all animals 0.0; iris all animals 0.0; redness of conjunctiva all animals 1.1; chemosis of conjunctiva all animals 1.1

Testing of Reactive Blue 198 for primary eye irritation in the rabbit showed, that the substance is slightly irritating to the eye.