CJ303

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 9, 2016 to October 19, 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:

Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride

Molecular formula:

C43H24ClCuN15O16S6.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 1341.9 < MW < 1374 g/mol (UVCB substance), and traces of NaCl and NaSO4

IUPAC Name:

Reaction products of cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, tetrasodium and lithium chloride

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: 2.0870-2.1238 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 ± 1, 48 ± 1, 72 ± 1 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 - 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

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
58	Female	2.0870	2.1260
59	Female	2.1238	2.1887
60	Female	2.0874	2.1322

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
58	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
59	1	Test	0	0	0	1	1	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
60	1	Test	0	0	0	1	1	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

^a Observation time was started after application of the test article

^b Left eye of the test rabbits

^c Right eye of the test rabbits

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ303 showed that no irritant to the eye. Therefore, CJ303 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100144001EN 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. Reversiblechemosisanddischargeof conjunctivae with score of 1 were observed within 1 hours after test article application. CJ303 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. Conjunctivachemosisanddischargewith 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 any irritant to the eye.