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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 08, 2017 to August 24, 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Granja RG (Suzano/SP-Brazil)
- Age at study initiation: 10 weeks old
- Weight at study initiation: 2443.8-3006.7 g
- Housing: individually in stainless steel cages
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22.8-23.0 °C
- Humidity (%): 50-64 %
- Photoperiod: 12hrs dark / 12hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.5 g test substance was moistened with 0.5 mL water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removing the bandage.

Number of animals:

Three

Details on study design:

- Area of exposure: the skin of back

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema 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:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1. Results of Dermal Irritation in the Periods of Evaluation.

Animal’s data				Reactions evaluation after application						Reactions evaluation after removal of the patch
				3 min		1 h		4 h		1 h		24 h		48 h		72 h
Animal#	Initial Weight (g)	Final Weight (g)	Sex	O	E	O	E	O	E	O	E	O	E	O	E	O	E
1	2443.8	2924.4	♂	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	3006.7	3274.4	♂	-	-	-	-	-	-	0	0	0	0	0	0	0	0
3	2852.5	2885.3	♂	-	-	-	-	-	-	0	0	0	0	0	0	0	0

O: Oedema; E: Erythema

 

Table 2. Clinical Signs.

Animal#	Clinical Signa
	After application			After removal of the patch
	3 min	1 hour	4 hours	1 hour	24 hours	48 hours	72 hours
1	0	0	0	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 404 test method test method, Everzol SR98 was non-irritant to skin. 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 16264.466.088.17. 0.5 g of Everzol SR98 moistened in 0.5 mL of purified water was applied to the skin of three New Zealand White rabbits and then covered with a gauze patch. After the 4 hours exposure period, the patches were removed, any residual test item removed using purified water and the animal #1 was evaluated after the application in the period of 3 minutes, 1 and 4 hours. After removing the bandage semiocclusive, three animals were examined skin reactions, behavioral and clinical alterations in approximately 1, 24, 48 and 72 hours. Adjacent untreated shaved areas of the skin were used as a negative control. Under test conditions, three rabbits do not showed any skin reactions and no treatment-related behavioral or clinical changes were observed during the observation period. On the basis of the test results given above, the response of Everzol SR98 was categorized as non-irritant.