Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 6, 2016 to January 4, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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:

Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate

EC Number:

260-976-0

EC Name:

Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate

Cas Number:

57834-33-0

Molecular formula:

C17H18N2O2

IUPAC Name:

ethyl 4-[[(methylphenylamino)methylene]amino]benzoate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Eversorb EP4
- Substance type: Liquid
- Composition of test material, percentage of components: 98.94%
- Lot/batch No.: 4023
- Storage condition of test material: Ambient

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: WEI XIN HANG
- Weight at study initiation: 2.0312 to 2.1223 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

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 normal saline

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hurs

Number of animals:

3

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:

edema score

Basis:

animal: 1, 2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

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. Body weight of the rabbits

Animal ID	Sex	Body weight (kg)
		Day 1	Day 4
73	Female	2.0828	2.1689
75	Female	2.0312	2.1125
76	Female	2.1223	2.2250

Table 2. Individual skin reactions

Animal I.D.	Observation time (hours)	Grading (erythema / edema)
		Test area		Control area
73	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
75	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
76	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 scores

Animal I.D.	Scores^a		Primary Irritation Scores (PIS)^b
	Test area	Control area
73	0	0	0
75	0	0	0
76	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).

^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 Eversorb EP4 was 0 and Eversorb EP4 was categorized as non-irritant. Therefore, Eversorb EP4 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100158001EN 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 Eversorb EP4 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 Eversorb EP4 was categorized as non-irritant.