Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]-, subsequently coupled with Urea, N-(3-aminophenyl)-, subsequently condensation with 1,3,5-Triazine, 2,4,6-trichloro-, further condensation with Benzenesulfonic acid, 3-amino- and 3-Pyridinecarboxylic acid, sodium salts

Endpoint summary

Description of key information

Skin irritation

The Primary Irritation Index (PII) of CR SB07 was 0 and CR SB07 was categorized as non-irritant (OECD TG404).

 

Eye irritation

CR SB07 was not any irritant to the eye (OECD TG405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 5, 2016 to October 13, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: WEI XIN HANG
- Weight at study initiation: 3.2013 to 3.2356 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: 12hrs dark / 12hrs light

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL normal saline

Duration of treatment / exposure:

Four hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

Three

Details on study design:

- Area of exposure: upper left and lower right dorsal area
- Washing (if done): with distilled water

Irritation parameter:

primary dermal irritation index (PDII)

Score:

0

Remarks on result:

no indication of irritation

Table 1. Body weight of the rabbits

Animal ID	Sex	Body weight (kg)
		Day 1	Day 4
05	Female	3.2244	3.2585
06	Female	3.2013	3.2445
09	Female	3.2356	3.2828

Table 2. Individual skin reactions

Animal I.D.	Observation time (hours)	Grading (erythema / edema)
		Test area		Control area
05	1	0/0	0/0	0/0	0/0
	24± 1	0/0	0/0	0/0	0/0
	48 ± 1	0/0	0/0	0/0	0/0
	72 ± 1	0/0	0/0	0/0	0/0
06	1	0/0	0/0	0/0	0/0
	24 ± 1	0/0	0/0	0/0	0/0
	48 ± 1	0/0	0/0	0/0	0/0
	72 ± 1	0/0	0/0	0/0	0/0
09	1	0/0	0/0	0/0	0/0
	24 ± 1	0/0	0/0	0/0	0/0
	48 ± 1	0/0	0/0	0/0	0/0
	72 ± 1	0/0	0/0	0/0	0/0

Table 3. Individual animal primary irritation score

Animal I.D.	Scores^a		Primary Irritation Scores (PIS)^b
	Test area	Control area
05	0	0	0
06	0	0	0
09	0	0	0
Primary Irritation Index (PII)^c= 0

^a Sum of scores at all time intervals on backside skin in each rabbit and divided the sum by the total number of observation.

^b PIS = (scores of test area) – (scores of control area).

^cPII = Sum of PIS÷number of animals.

 

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 404 test method and Evaluation table for single dermal irritation, the PII for CR SB07 was 0 and CR SB07 was categorized as non-irritant. Therefore, CR SB07 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100053001EN which is based on the SOP for the OECD 404 (SOPP-305) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB07 was calculated to be 0. On the basis of the test results given above and according to Evaluation table for single dermal irritation, the response of CR SB07 was categorized as non-irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 05, 2016 to October 11, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: WEI XIN HANG
- Weight at study initiation: 2.8030-3.3330 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

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

Irritation parameter:

cornea opacity score

Basis:

animal: #01, #04 and #10

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: #01, #04 and #10

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: #01, #04 and #10

Time point:

24/48/72 h

Max. score:

0.33

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: #01, #04 and #10

Time point:

24/48/72 h

Max. score:

0.33

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Table 1. Body weight of the rabbits

Animal ID	Sex	Body weight (kg)
		Day 1	Day 4
01	Female	2.8030	2.8488
04	Female	3.3330	3.3809
10	Female	2.8038	2.8538

 

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
01	1	Test^b	0	0	1	0	2	0
		Control^c	0	0	0	0	0	0
	24 ± 1	Test	0	0	1	1	0	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
04	1	Test	0	0	1	1	2	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	0	0	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
10	1	Test	0	0	1	1	2	0
		Control	0	0	0	0	0	0
	24 ± 1	Test	0	0	0	0	0	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

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CR SB07 showed that non-irritant to the eye. Therefore, CR SB07 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100062001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). CR SB07 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 conjunctivalredness, chemosisanddischargewas observed within 48 hours after test article application.On the basis of the test results given above, the response of the test article was non-irritant to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB07 was calculated to be 0. On the basis of the test results given above and according to Evaluation table for single dermal irritation, the response of CR SB07 was categorized as non-irritant.

 

Eye irritation

CR SB07 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 conjunctivalredness, chemosisanddischargewas observed within 72 hours after test article application.On the basis of the test results given above, the response of the test article was not any irritant to the eye.