hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 06, 2017 to May 18, 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:

hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

EC Number:

943-299-1

Molecular formula:

C52H46Cl2N14O29S9 . 6 Na

IUPAC Name:

hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

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 4-5 months
- Weight at study initiation: 2812-3208 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 day

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:

animal: #1 and #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24 hours

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) (D4-D1)	Clinical observation
	D1	D4
4	2812	2840	28	Normal^1
5	3169	3130	-39	Normal^2
6	3208	3247	39	Normal^2

1: D1-D14

2: D1-D7

 

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
4	1 h	0/-	0^3	1/1
	24 h	0/-	0^3	1/1
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	0/0
	Day 7	-	0^3	-
	Day 14	-	Normal	-
5	1 h	0/-	0^3	1/1
	24 h	0/-	0^3	1/0
	48 h	0/-	0^3	0/0
	72 h	0/-	0^3	0/0
	Day 7	-	Normal	-
6	1 h	0/-	0^3	1/1
	24 h	0/-	0^3	1/0
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	0/0
	Day 7	-	Normal	-

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

²(R/D) = (Redness/Chemosis)

³Iris stained, deep pink

-: Not available

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CR SB32N2 showed that was not positive irritant to the eye. Therefore, CR SB32N2 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316008-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). CR SB32N2 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 14 days. There were no test article effects on body weight. No irritation reaction in cornea and iris. Reversible conjunctiva redness and chemosis were observed within 72 hours after test article application. 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.