5-({4-chloro-6-[(2-methylphenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfophenyl)diazenyl]naphthalene-2,7-disulfonic 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 February 16, 2016 to November 08, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The structure of the read-across substance, EC:300-504-3, is the same as the test substance. Therefore, the human toxicity and environmental toxicity is the same. The only difference is the test substance containing lithium. However, the low level of lithium will not change the classification.

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 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

300-504-3

EC Name:

Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

93941-05-0

Molecular formula:

C26H20ClN7O10S3.3Na

IUPAC Name:

trisodium 5-({4-chloro-6-[(2-methylphenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Evercion SR61
- Substance type: Powder
- Composition of test material, percentage of components: 84.05 %
- Lot/batch No.: 4501
- Storage condition of test material: Ambient

Specific details on test material used for the study:

Evercion SR61, Reactive red 3-1, EC: 300-504-3

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: 2.6412-3.4180 kg
- Housing: individually in a stainless steel 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 hour

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:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal:

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak 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
21	Female	3.4180	3.4394
22	Female	2.8186	2.8698
24	Female	2.6412	2.6926

Table 2. Individual response of the test rabbits

Animal I.D.	Time^a (hour)	Observation site	Grades of the irritation reaction
			Cornea		Conjunctivae			Iris
			Opacity	Area	Redness	Chemosis	Discharge
21	1	Test^b	0	0	1	2	0	1
		Control^c	0	0	0	0	0	0
	24 ± 1	Test	0	0	1	0	0	1
		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
22	1	Test	0	0	1	1	0	1
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	1	0	0	1
		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
24	1	Test	0	0	1	2	0	1
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	1	0	0	1
		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, the reactions are below 1 and fully recovered within 48 hr . Therefore, Evercion SR61 is not classified based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100094001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). Evercion SR61 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. There were no test article effects on body weight. Redness and chemosisof conjunctivae and iris with score of 1-2 were observed within 24 hours after test article application and fully recovered within 48 hours. On the basis of the test results given above, the test article is not classified.