2-[{6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazenyl]naphthalene-1,5-disulfonic acid, lithium sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Decenber 29, 2015 to February 18, 2016 Single exposure, 72 hours observation (reversible changes)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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:

2-[{6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazenyl]naphthalene-1,5-disulfonic acid, lithium sodium salts

EC Number:

942-710-1

Molecular formula:

Not applicable; this UVCB substance contains: C24H15ClN7O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 713.8 < MW < 762.0 g/mol (UVCB substance), C24H16N7O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 695.4 < MW < 743.5 g/mol (UVCB substnace), C21H14N3O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 585.3 < MW < 633.5 g/mol (UVCB substnace), and traces of NaCl.

IUPAC Name:

2-[{6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazenyl]naphthalene-1,5-disulfonic acid, lithium sodium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Kitayama Labes Co., Ltd. (Japan)
- Age at study initiation: approximately 5 to 6 months
- Weight at study initiation: 2891 to 3910 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

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 0.3 mL water for injection

Duration of treatment / exposure:

4-4.5 hours

Observation period:

1, 24, 48, 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:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Score:

0.22

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of mild 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	2891	2931	40	Normal
2	3910	3929	19	Normal
3	3031	3049	18	Normal

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

Animal ID	1				2				3
	Score on each observation point (hour)
	1	24	48	72	1	24	48	72	1	24	48	72
Control site
Erythema	0	0	0	0	0	0	0	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0	0	0	0
Total irritation score for vehicle*	0				0				0
Test site
Erythema	1	1	1	0	0	0	0	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0	0	0	0
Total irritation score for vehicle*	2				0				0
PII**	0.22

* The sum of scores at 24, 48 and 72 hours.

** (Total irritation score for test article-Total irritation score for vehicle)/9

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 result does not meet the CLP criteria. Therefore, CJ302 is not classified.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315014-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. Erythema with score 1 was observed in one animal during 48 hours after patch removal. The Primary Irritation Index for CJ302 was calculated to be 0.22. On the basis of the test results given above and according to Draize Dermal Classification System, the response of CJ302 was not classified.