hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 06, 2017 to May 18, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

EC Number:

943-299-1

Molecular formula:

C52H46Cl2N14O29S9 . 6 Na

IUPAC Name:

hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: approximately 4 to 5 months
- Weight at study initiation: 2924 to 3276 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12hrs dark / 12hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

Water for injection (WFI)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.4 mL water for injection

Duration of treatment / exposure:

4-4.5 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

three

Details on study design:

- Area of exposure: left dorsal area
- Washing (if done): with lukewarm water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1. Individual Body Weights and Clinical Observations

Animal ID	Body weight (g)		Body weight change (g)	Clinical observation
	D1	D4	D4-D1
1	2956	2955	-1	Normal
2	2924	3057	133	Normal
3	3276	3354	78	Normal

Table 2. Individual Scores and Total Scores for Skin Irritation During 72 hours

Animal ID	Observation point	Erythema	Edema
Control Site
1	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
2	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
3	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
Test Site
1	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
2	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
3	1 h	0	0
	24 h	0	0
	48 h	0	0
	72 h	0	0
Total irritation score = 0
PII = 0

Total irritation score = The sum of irritation score got from test site at 24, 48 and 72h minus the sum of irritation score got from control site at the same time points.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 404 test method and Draize Dermal Classification System, the PII for CR SB32N2 in intact skin was 0 and CR SB32N2 was categorized as non-irritant. CR SB32N2 was not met classification on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316009-IR which is based on the SOP for the OECD 404 (CTPS-TE00440) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. Neither erythema nor edema was observed within 72 hours. The Primary Irritation Index for CR SB32N2 was calculated to be 0. On the basis of the test results given above and according to Draize Dermal Classification System, the response of CR SB32N2 was categorized as non-irritant.