Pyridinium, 1-[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulfo-1-anthracenyl)amino]cyclohexyl]amino]-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]-3-carboxy-, inner salt, sodium salt (1:3)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 16, 2016 to June 27, 2016

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other company data

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:

trisodium 1-[4-({4-[(4-amino-9,10-dioxo-3-sulfonato-9,10-dihydroanthracen-1-yl)amino]cyclohexyl}amino)-6-[(2,5-disulfonatophenyl)amino]-1,3,5-triazin-2-yl]-1λ⁵-pyridin-1-ylium-3-carboxylate

EC Number:

813-042-7

Cas Number:

1918149-24-2

Molecular formula:

C35H30N8O13S3 . 3Na

IUPAC Name:

trisodium 1-[4-({4-[(4-amino-9,10-dioxo-3-sulfonato-9,10-dihydroanthracen-1-yl)amino]cyclohexyl}amino)-6-[(2,5-disulfonatophenyl)amino]-1,3,5-triazin-2-yl]-1λ⁵-pyridin-1-ylium-3-carboxylate

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: WEI XIN HANG
- Weight at study initiation: 2.8282-2.9954 kg
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- 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

Duration of treatment / exposure:

1 hours

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:

animal: #18, #19 and #20

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #18, #19 and #20

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: #18, #19 and #20

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #18, #19 and #20

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1. Body weight of the rabbits

Animal ID	Sex	Body weight (kg)
		Day 1	Day 4
18	Female	2.9954	3.0392
19	Female	2.6542	2.6986
20	Female	2.8282	2.9162

Table 2. Individual response of the test rabbits

Animal I.D.	Time^a (hour)		Grades of the irritation reaction
			Cornea		Conjunctivae			Iris
			Opacity	Area	Redness	Chemosis	Discharge
18	1	Test^b	0	0	0	1	0	0
		Control^c	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	48 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	72 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
19	1	Test	0	0	0	1	0	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	48 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	72 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
20	1	Test	0	0	0	1	0	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	48 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0
	72 ± 1	Test	0	0	0	0	0	0
		Control	0	0	0	0	0	0

^aObservation time was started after application of the test article

^bLeft eye of the test rabbits

^cRight eye of the test rabbits

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CR SB08 showed that no irritant to the eye. Therefore, CR SB08 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100078001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). There were no test article effects on body weight.Reversiblechemosiswith score of 1 was observed within 1 hours after test article application.CR SB08 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination within 72 hoursand a 4 days clinical observation period. Conjunctivachemosiswith score 1 was determined within 24 hours and fully recovered. On the basis of the test results given above, the response of the test article was not any irritant to the eye.