2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic 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 December 23, 2016 to April 13, 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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic acid, lithium sodium salts

EC Number:

943-083-7

Cas Number:

118578-12-4

Molecular formula:

Not applicable; this UVCB substance contains: C30H15ClN7O15S4.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 911.8 < MW < 992.1 g/mol (UVCB substance), C30H16N7O16S4.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 893.4 < MW < 973.7 g/mol (UVCB substnace), C23H11Cl2N6O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 719.3 < MW < 767.4 g/mol (UVCB substnace), and traces of NaCl.

IUPAC Name:

2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic acid, lithium sodium salts

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: approximately 2-3 months
- Weight at study initiation: 2181-2207 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): 0.1 g

Observation period (in vivo):

1, 24, 48, 72 hours and 7, 14, 21 Days

Number of animals or in vitro replicates:

Three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #4, #5 and #6

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:

animal: #4, #5 and #6

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:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: Day7

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive 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) (D4-D1)	Clinical observation between D1 and D21
	D1	D4
04	2194	2272	78	Normal
05	2207	2245	38	Normal
06	2181	2260	79	Normal

Table 2. Eye Irritation Scores at Observation Point on Treated Eye

Animal I.D.	Observation point	Cornea (D/A)^1	Iris	Conjunctivae (R/D)^2
04	1 h	0/-	0	2/1
	24 h	0/-	0^3	0/0
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	1/0
	D7	0/-	0^3	0/0
	D14	-	-^3	-
	D21	-	Normal	-
05	1 h	0/-	0	2/1
	24 h	0/-	0^3	0/0
	48 h	0/-	0^3	0/0
	72 h	0/-	0^3	0/0
	D7	-	-^3	-
	D14	-	-^3	-
	D21	-	Normal	-
06	1 h	0/-	0	2/1
	24 h	0/-	0^3	2/3
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	0/0
	D7	-	-^3	-
	D14	-	-^3	-
	D21	-	-^3	-

¹ (D/A) = (Degree of density/Area of opacity)                                                                

² (R/D) = (Redness/Chemosis)

³ Deep pink colored iris

-: Not available

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ308 showed that positive irritant to the eye. Therefore, CJ308 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316005-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). CJ308 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination and clinical observation no more than 21 days. There were no test article effects on body weight. Reversible conjunctivalredness and chemosiswas observed within 7 days after test article application. On the basis of the test results given above, the response of the test article was judged as a light irritant to the eye.

However, the result has not met a category based on GHS criteria.