7-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazenyl]naphthalene-1,3,6-trisulfonic 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 March 09, 2016 to June 01, 2016

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:

dilithium(1+) sodium 7-[(1E)-2-{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazen-1-yl]naphthalene-1,3,6-trisulfonate

EC Number:

942-667-9

Molecular formula:

Not applicable; this UVCB substance contains: C20H13ClN9O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 691.8 < MW < 739.9 g/mol (UVCB substance), C20H14N9O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 673.4 < MW < 721.5 g/mol (UVCB substnace), and traces of NaCl.

IUPAC Name:

dilithium(1+) sodium 7-[(1E)-2-{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazen-1-yl]naphthalene-1,3,6-trisulfonate

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: 3422 to 3462 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)

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
10	3422	3706	284	Normal
11	3428	3607	179	Normal
12	3462	3627	165	Normal

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

Animal ID	10				11				12
	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	0	0	0	0	1	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
PII**	0

* 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 PII for CJ312 in intact skin was 0 and CJ312 was categorized as non-irritant. CJ312 was not met classification on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315018-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. Score 1 erythema was observed in one animal at 1 hour after patch removal. The Primary Irritation Index for CJ312 was calculated to be 0.On the basis of the test results given above and according to Draize Dermal Classification System, the response of CJ312 was categorized as non-irritant.