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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 28, 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: 4-5 months
- Weight at study initiation: 3124-4041 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: 12-hrs dark / 12-hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity 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:

iris 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:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. 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
16	3879	3913	34	Normal
17	3124	3118	-6	Normal
18	4041	4049	-8	Normal

Table 2. Eye Irritation Scores at Observation Point (hour) on Treated Eye

Animal ID	16				17				18
	Score on each observation point (hour)
	1	24	48	72	1	24	48	72	1	24	48	72
Cornea
Degree of density	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0^1	0^1	0^1	0	0^1	0^1	0^1	0	0^1	0^1	0^1	0
Conjunctive
Redness	1	0	0	0	1	0	0	0	1	1	1	0
Chemosis	0	0	0	0	0	0	0	0	0	0	0	0

1: Iris discoloration

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ312 showed that no positive irritant to the eye. Therefore, CJ312 was not met GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315012-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).There were no CJ312 effects on mortality, clinical observations and body weight.Reversible redness of conjunctivae with score of 1 was observed within 48 hours after CJ312 application. Moreover, iris discoloration was observed.CJ312 was given by a single ocular application at 100 mg amount toNZW male rabbits and followed by ocular examinationwith 72 hours and a 4days clinical observation period. Conjunctiva redness with score 1 was determined within 48 hours and filly recovered. On the basis of the test results given above, the response of CJ312was not judged as a positive irritant to the eye.