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]

Endpoint summary

Description of key information

Six rabbits were exposed dermally (under occlusion) to 0.5 g of the substance for 24 hours. Very limited oedema and erythema were reported at the 24 h examination. These effects were fully reversible after 72 hours. The substance is not irritating to the skin (Ciba 1974).

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 (Ciba 1974)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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: Non-GLP test which contains sufficient information to allow a conclusion (worst case exposure under occlusion during 24 hours)

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test substance applied under occlusion to 2.5 cm2 for 24 hours; readings at 24 and 72 hours

Principles of method if other than guideline:

6 animals were treated at both flanks, one of these sides was abraded before application. Only the results for the intact side are reported in this smmary.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on premisses
- Strain: Porton
- Age at study initiation: 11-12 weeks
- Average weight at study initiation: 4 males 2.39 kg; 2 females 2.48 kg
- Housing: individually
- Diet: Styles-Oxoid (irridiated) ad libitum
- Water: sterilised ad libitum
- Acclimation period: 1 week

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

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.66 g/mL

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.75 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

4 males and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2 - Type of wrap if used: covered with aluminium foil secured with "Sleek" adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: similar to Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

>= 0 - <= 0.33

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: mean at 24 h 0.33

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

>= 0 - < 0.67

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: mean at 24 h 0.67

Irritant / corrosive response data:

non irritant

Other effects:

none reported

Animal	erythema		oedema
	24h	72h	24h	72h
1	1	0	1	0
2	0	0	0	0
3	0	0	0	0
4	0	0	0	0
5	0	0	1	0
6	1	0	2	0

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is considered not irritating to the skin

Executive summary:

Six rabbits were exposed dermally (under occlusion) to 0.5 g of the substance for 24 hours. Very limited oedema and erythema were reported at the 24 h examination. These effects were fully reversible after 72 hours. The substance is not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

no

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.04

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24-72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

1

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

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

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data the substance does not need to be classified for skin and eye irritation according to Regulation ((EC) No 1272/2008 (CLP)