2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 3, 2017 to March 6, 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:

2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

EC Number:

815-135-8

Cas Number:

1386899-40-6

Molecular formula:

C26H25N5O22S7.5Na

IUPAC Name:

2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

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: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one rabbit per cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12hrs dark / 12hrs light

Test system

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 physiological saline

Duration of treatment / exposure:

4 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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema 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:

edema 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:

primary dermal irritation index (PDII)

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. The body weight of the rabbits during the study period

Animal ID	Sex	Body weight (kg)
		Day 1	Day 4
180	Male	2.86	2.90
181	Male	3.12	3.13
182	Male	2.85	2.92

Table 2. The results of rabbit skin irritation response

Animal I.D.	Observation time (hours)	Skin grading (erythema / edema)
		Test area		Control area
180	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
181	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
182	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. Primary irritation scores of rabbit skin irritation test

Animal I.D.	Irritation scores^a		Primary Irritation Scores (PIS)^b
	Test area	Control area
180	0	0	0
181	0	0	0
182	0	0	0
Primary Irritation Index (PII)^c= 0

^a Irritation scores were the sum of each rabbit irritation values at three time points and then divided by the total number of observation.

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

^c PII = Sum of PIS÷number of animals.

Applicant's summary and conclusion

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 SB37 was 0 and CR SB37 was categorized as non-irritant. Therefore, CR SB37 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-170900008002EN 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 SB37 was calculated to be 0. On the basis of the test results given above and according toEvaluation table for single dermal irritation, the response of CR SB37 was categorized as non-irritant.