1,5-Naphthalenedisulfonic acid, 2-[2-[8-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:5)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EWG, B.5; OECD 405

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

402-420-3

EC Name:

-

Cas Number:

89157-03-9

Molecular formula:

C31H19ClN7Na5O19S6

IUPAC Name:

pentasodium 5-{[4-chloro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Red 239

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca 3-5 months
- Weight at study initiation: 2.5-3.3 kg
- Housing: single
- Diet: Altromin 2123, 15 g daily
- Water (ad libitum): deionized, chlorinated water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14.10.1986 To: 17.10.1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

single application

Observation period (in vivo):

after 24h, 48h and 72h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline 37°C
- Time after start of exposure: 24 h and after each fluorescein staining

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein 0.01%

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Other effects:

Clear conjunctival chemosis was observed in the animals one hour p.a. Due to dye depositions, conjunctival redness and inflammation of the iris could not be assessed at this point in time. In addition, a lilac efflux caused by the substance occurred. 24 h p.a. the conjunctivae of all of the animals exhibited clear hyperaemia in some blood vessels and slight chemosis. The iris was reddened. As from 24 h p.a. all of the animals were free from signs of irritation. In addition to the signs of irritation which occurred, as from 24 h p.a. the iris, conjunctivae and nictitating membrane, and as from 48 hours p.a. the eyeball too, were discolored by the substance.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The evaluation of the eye irritation in the rabbit revealed that Reactive Red 239 is not an eye irritant.

Executive summary:

The evaluation of the eye irritation in the rabbit revealed that Reactive Red 239 is not an eye irritant.