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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 07, 2016 to January 25, 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 402 (Acute Dermal Toxicity)

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7-8 weeks old (males); about 9-10 weeks old (females)
- Housing: Animals were individually housed with bedding and an enrichment toy.
- Acclimation period: 6 Days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

Water for Injection (WFI)

Duration of exposure:

24 hours

Doses:

2,000 mg/kg B.W.

No. of animals per sex per dose:

For Group 1: six male and six female
For Group 2: six male and six female

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other:

Any other information on results incl. tables

Table 1. Clinical Observations

Dose (mg/kg)	0	2000
Group	1	2
Red lacrimation
Male	1/6	1/6
Female	0/6	0/6
Red hair stain on nose
Male	5/6	5/6
Female	3/6	5/6
Skin laceration on neck
Male	0/6	1/6
Female	0/6	0/6
Skin scab/scar on neck/back
Male	1/6	1/6
Female	0/6	0/6
Skin swelling on thorax
Male	0/6	0/6
Female	0/6	1/6

Table 2. Body Weight and Body Weight Gains

Dose (mg/kg)	0	2000
Group	1	2
Male
Body weight (g)
D1	253	253
D15	343	349
Weight gain
Absolute (g)	+90	+96
Relative to D1 (%)	+36%	+38%
Female
Body weight (g)
D1	233	230
D15	266	262
Weight gain
Absolute (g)	+33	+32
Relative to D1 (%)	+14%	+14%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 402 test method, the LD50 of Eversorb EP4 was greater than 2000 mg/kg B.W.. Therefore, Eversorb EP4 was Category 5 based on GHS criteria. According to CLP, category 5 is not used. The test substance is not classified.

Executive summary:

This test using the procedures outlined in the QPS study for T65316017-GN and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in test. For Dose Group 2, 12 Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Eversorb EP4. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Eversorb EP4 was greater than 2,000 mg/kg B.W..