Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]

EC Number:

269-284-3

EC Name:

Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]

Cas Number:

68214-04-0

Molecular formula:

C44H24Cl2N14Na6O20S6

IUPAC Name:

hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: own breeding
- Age at study initiation: 12-13 weeks
- Average weight at study initiation: 4 males 2.39 kg; 2 females 2.48 kg
- Housing: individually
- Diet: ad libitum (Styles-Oxoid)
- Water: sterile filtered water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50-70%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg (0.1 mL)

Duration of treatment / exposure:

single treatment, in 3 animals eyes were washed after 1 hour

Observation period (in vivo):

1, 6, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

4 males and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes in 3 animals
- Time after start of exposure: after 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 mL of warm water.

SCORING SYSTEM: similar to Draize (Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the USA )

TOOL USED TO ASSESS SCORE: none mentioned

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.04

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24-72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

1

Results 5

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

very slight difference between animals with eyes washed or not

Any other information on results incl. tables

Animal no	1					2					3	washed
	1	6	24	48	72	1	6	24	48	72	1	6	24	48	72
cornea	1	1	1	1	0	1	1	0	0	0	1	1	0	0	0
iris	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
conjunctivae
redness	2	2	0	0	0	2	2	1	1	0	1	1	1	1	0
chemosis	1	1	0	0	0	1	0	0	0	0	1	0	0	0	0
discharge	2	0	0	0	0	3	0	0	0	0	1	0	0	0	0
Animal no	4					5	washed				6	washed
	1	6	24	48	72	1	6	24	48	72	1	6	24	48	72
cornea	1	1	0	0	0	1	1	0	0	0	0	0	0	0	0
iris	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
conjunctivae
redness	2	2	1	1	0	1	2	0	0	0	2	2	0	0	0
chemosis	1	1	0	0	0	1	1	0	0	0	1	1	0	0	0
discharge	3	1	0	0	0	2	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the eyes

Executive summary:

A study similar to OECD 405 was performed. The substance was installed in the conjuntival sac of the eye of 6 rabbits. The eyes of 3 of these were washed after 30 seconds. Observations for irritancy were done at 1, 6, 24, 48 and 72 hours after installation. No irritant effects became apparent except for slight cornea effects and slight redness that were fully reversible after 72 hours. There was no difference between animals with washed eyes and animals that were not washed. Therefore it is concluded that the substance is not irritating to the eyes