Pyridinium, 1-[2-[[4-[[3-[2-[6-amino-1-hydroxy-3-sulfo-5-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-2-naphthalenyl]diazenyl]-4-sulfophenyl]amino]-4-oxobutyl]sulfonyl]ethyl]-3-carboxy-, inner salt, sodium salt (1:4)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 4, 2019 to March 14, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

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:

2-​Naphthalenesulfonic acid, 7-​amino-​4-​hydroxy-​, coupled with diazotized 2-​amino-​5-​[[2-​(sulfooxy)​ethyl]​sulfonyl]​benzenesulfonic acid and diazotized dehydrochlorinated 2-​amino-​4-​[[4-​[(2-​chloroethyl)​sulfonyl]​-​1-​oxobutyl]​amino]​benzenesulfonic acid, sodium salts

EC Number:

833-951-2

Cas Number:

2246977-27-3

Molecular formula:

C8H11NO9S3.C10H9NO4S.C12H17ClN2O6S2.Na

IUPAC Name:

2-​Naphthalenesulfonic acid, 7-​amino-​4-​hydroxy-​, coupled with diazotized 2-​amino-​5-​[[2-​(sulfooxy)​ethyl]​sulfonyl]​benzenesulfonic acid and diazotized dehydrochlorinated 2-​amino-​4-​[[4-​[(2-​chloroethyl)​sulfonyl]​-​1-​oxobutyl]​amino]​benzenesulfonic acid, sodium salts

Test material form:

solid: particulate/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: 2.00-2.60 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 vehicle

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

Details on study design:

After evaluating, test article had not been judged to be corrosive, so test article did not perform preliminary test and directly applied on main test.

The form of test article is powder and the test article (0.1g) was directly applied to the conjunctival sac of the left eye of each rabbits, then cover the eye for 5 seconds to prevent the test article following out. The right eye does not perform any test as blank control. The test article has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of 1 hour after treatment, the eye were rinsed with physiological saline. There was no anesthetic treatment during the study period.

Both eyes of the three rabbits were examined and grading at 1, 25, 49, and 73 hours after test article application according to the grades of: System for grading ocular lesions”.

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:

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	Day 1	Day 4
153	male	2.08	2.60
154	male	2.00	2.07
155	male	2.00	2.10

Table 2. Individual skin reactions

Animal ID	Time^a(hours)	Test dosing	Grades of the irritation reaction                Cornea  Conjunctivae Opacity     Area Redness Chemosis Discharge Iris
156	1	Test^b	0	0	0	0	0	0
156	25	-^c	0	0	0	0	0	0
156	49	Test^b	0	0	0	0	0	0
156	73	-^c	0	0	0	0	0	0
157	1	Test^b	0	0	0	0	0	0
157	25	-^c	0	0	0	0	0	0
157	49	Test^b	0	0	0	0	0	0
157	73	-^c	0	0	0	0	0	0
158	1	Test^b	0	0	0	0	0	0
158	25	-^c	0	0	0	0	0	0
158	49	Test^b	0	0	0	0	0	0
158	73	-^c	0	0	0	0	0	0

^aObservation time was started after application of the test article.

^bLeft eye of the test rabbits were dosed with test article.

^cRight eye of the test rabbits were not perform any test as blank control.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CR SB33 showed that no irritant to the eye. Therefore, CR SB33 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for MZ6-181200023 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. Both eyes of the test animals were examined at 1, 25, 49, and 73 hours after the test article application. Results indicated that all of the three rabbits did not show any eye irritation response within the observation period, grades of the irritation reaction were 0. Therefore, the test article CR SB33 did not cause any irritation response on the eye of rabbits under the conditions designed for this study and did not classify as eye irritants.