Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[(2-hydroxyethyl)sulfonyl]- , subsequently coupled with 3,5-Diaminobenzoic acid, further coupled with diazotised Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 11, 2016 to October 15, 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 diazotised Benzenesulfonic acid, 2-amino-5-[(2-hydroxyethyl)sulfonyl]- , subsequently coupled with 3,5-Diaminobenzoic acid, further coupled with diazotised Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts

EC Number:

944-505-2

Molecular formula:

C8H11NO6S2 . C7H8N2O2 . C8H11NO6S2 . Na

IUPAC Name:

Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[(2-hydroxyethyl)sulfonyl]- , subsequently coupled with 3,5-Diaminobenzoic acid, further coupled with diazotised Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), 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: 2.1086-2.3962 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: #43, #45 and #48

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #43, #45 and #48

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: #43, #45 and #48

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #43, #45 and #48

Time point:

24/48/72 h

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak 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
43	Female	2.2104	2.2492
45	Female	2.1086	2.1508
48	Female	2.3962	2.4366

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
43	1	Test^b	0	0	0	3	2	0
		Control^c	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	2	1	0
		Control	0	0	0	0	0	0
	48 ± 1	Test	0	0	0	1	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
45	1	Test	0	0	0	1	2	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	1	1	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
48	1	Test	0	0	0	1	2	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	1	1	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, CR SB87 showed that weak irritant to the eye. Therefore, CR SB87 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100126001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). CR SB87 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. Reversible conjunctival chemosis and discharge was observed within 72 hours after test article application. On the basis of the test results given above, the response of the test article was weak irritant to the eye.