Reaction products of 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and 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 December 08, 2017 to March 19, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate), sodium salts

EC Number:

948-044-8

Molecular formula:

C10H5N3O6S.C10H9NO4S.C2H4O2.1/3Cr.Co.H2O4S.7H2O.C3Cl3N3.C8H11NO6S2.xNa

IUPAC Name:

Reaction products of 4-Diazo-3,4-dihydro-7-nitro-3-oxo-1-naphthalenesulfonic acid coupled with 7-Amino-4-hydroxy-2-naphthalenesulfonic acid, subsequently chelated with Chromium(3+) and cobalt(3+), further mixed with reaction products of 2,4,6-Trichloro-1,3,5-triazine and 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: Granja RG Suzano/SP, Brasil
- Age at study initiation: 10 weeks old
- Weight at study initiation: 2413.6 to 2616.7 g
- Housing: individually in stainless steel cages
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22.8 to 23.0 °C
- Humidity (%): 50 to 64 %
- 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):

Approximately 1, 24, 48, 72 hours after the application of test substance.

Number of animals or in vitro replicates:

Three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #2

Time point:

24/48/72 h

Score:

0.33

Any other information on results incl. tables

Table 1. Initial and Final Weights of the Animals and Grading of Ocular Reactions Observed during the Test.

Animal #		01				02				03
Weight (g)	Initial	2413.6				2413.8				2616.7
	Final	2775.6				2473.3				2751.7
Sex		♀				♀				♀
Observation period		Hours				Hours				Hours
		1	24	48	72	1	24	48	72	1	24	48	72
Cornea	Opacity	0	0	0	0	0	0	0	0	0	0	0	0
	Area	0	0	0	0	0	0	0	0	0	0	0	0
Iris	Irite	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae	Hyperemia	1	0	0	0	1	0	0	0	1	1	0	0
	Chemosis	2	1	0	0	2	1	0	0	2	1	0	0
	Secretion	-	-	-	-	-	-	-	-	-	-	-	-
Lesion	Fluorescein retention	NR	-	-	-	NR	-	-	-	NR	-	-	-

+: Presence; -: Ausence; NR: Not realized

Table 2. Clinical Signs

Animal #	Clinical Signs / Period of Evaluation
	01 hour	24 hours	48 hours	72 hours
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0

0: None visual alterations observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, Everzol SR98 showed that non-irritant to the eye. Therefore, Everzol SR98 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the BIOAGRI Study Plan for 16264.465.102.17. All the animals presented body weight gain during the observation period. The test was initially conducted using one New Zealand White rabbit. Because no severe ocular reaction was observed in the initial test, two additional New Zealand White rabbits were tested to confirm the response. Each animal received a 0.1 g dose of pure test item in the conjunctival sac of the right eye. After application the animals were examined the ocular reaction, behavioral and clinical alterations at approximately 1, 24, 48 and 72 hours. The untreated left eye was used as a negative control. The Everzol SR98 applied in tested eye of all rabbits caused hyperemia and chemosis and do not have retention of fluorescein sodium dye on the surface of the cornea. After the evaluation of 48 hours, there was regression of eyes reactions in tested eyes of all rabbits. After the evaluation of 72 hours, finalizing the study and all rabbits do not note any behavioral or clinical change related to treatment during the observation period.