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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 15, 2016 to June 1, 2016. single exposure, 96 hours observation period (revsersible)

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:

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 / 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: 3274-3503 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

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48hr

Remarks on result:

probability of weak 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	3491	3511	20	Normal
2	3274	3397	123	Normal
3	3503	3552	49	Normal

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

Animal ID	1				2				3
	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	0	0	0	0	0	0	0	0	0	0	0
Conjunctiva
Redness	1	0	0	0	1	0	0	0	1	0	0	0
Chemosis	1	1	0	0	0	1	0	0	1	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ302 showed that no positive irritant to the eye. Therefore, CJ302 was not met GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315008-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). There were no test article effects on mortality, clinical observations and body weight. Reversible redness of conjunctivae and chemosis with score of 1 were observed within 24 hours after test article application.CJ302 was given by a single ocular application at 100 mg amount to NZW male rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. Conjunctiva redness and chemosis with score 1 were determined within 24 hours and fully recovered. On the basis of the test results given above, the response of the test article was not judged as a positive irritant to the eye.