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]

Skin irritation / corrosion

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

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

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

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.