CJ309

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 01, 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 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt and lithium chloride

Molecular formula:

Not applicable; this UVCB substance contains: C25H14ClN10O16S5.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 940.9 < MW < 1021.1 g/mol (UVCB substance), and traces of NaCl.

IUPAC Name:

Reaction products of 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt 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: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: 4-5 months
- Weight at study initiation: 3375-3710 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 hrs

Observation period (in vivo):

1hrs, 24hrs, 48hrs, 48 hrs, 7 days and 14 days

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

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

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
13	3710	3732	22	Normal
14	3375	3390	15	Normal
15	3580	3577	-3	Normal

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

Animal ID	13				14				15
	Score on each observation point
	1hr	24hr	48hr	72hr	1hr	24hr	48hr	72hr	1hr	24hr	48hr	72hr	7day	14day
Cornea
Degree of density	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0^1	0	0	0	0^1	0	0	0	0	0^1	0^1
Conjunctiva
Redness	1	0	0	0	0	1	0	0	0	0	0	1	1	0
Chemosis	1	0	0	0	1	1	0	0	1	0	1	1	0	0

1: Iris discoloration

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ309 showed that no positive irritant to the eye. Therefore, CJ309 was not met GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315011-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. No irritation effects were observed at cornea and iris of treated eye throughout the study period. Grade 1 diffused redness of conjunctive and chemosis were observed in rabbits during 72 h after dosing. Until D14, all eye irritation effects were not observed. Moreover, iris discoloration was observed.CJ309 was given by a single ocular application at 100 mg amount toNZW male rabbits and followed by ocular examination and clinical observation for 14 days. Reversible grade 1 conjunctiva redness and chemosis were observed with 14 days. On the basis of the test results given above, the response of the test articlewas not judged as a positive irritant to the eye.