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Registration Dossier
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EC number: 260-976-0 | CAS number: 57834-33-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 29, 2016 to January 04, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: about 8 week old
- Housing: two animals per cage
- Water: ad libitum
- Acclimation period: at least 7 days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg B.W.
- No. of animals per sex per dose:
- For Group 1: Three female
For Group 2: Three female
Results and discussion
Effect levels
- Key result
- Sex:
- 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. Body weight of the rats in the study period
Animal I.D. |
Dosing volume (mL) |
Body weight (g) |
Weight changes (g) |
|
Day 1 |
Day 14 |
|||
Group 1 |
||||
01F |
2.1 |
206.6 |
237.9 |
+31.3 |
02F |
2.1 |
208.6 |
241.7 |
+33.1 |
03F |
2.1 |
208.6 |
244.2 |
+35.6 |
Group 2 |
||||
04F |
2.2 |
210.8 |
242.4 |
+31.6 |
05F |
2.2 |
217.2 |
257.0 |
+39.8 |
06F |
2.2 |
217.8 |
259.6 |
+41.8 |
Table 2. Clinical observation of the rats
Animal I.D. |
Clinical sign observation |
||||||||||||||
30 mins |
4 hrs |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
|
Group 1 |
|||||||||||||||
01F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
02F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
03F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Group2 |
|||||||||||||||
04F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
05F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
06F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N: Normal.
D2-D14: Day 2-Day 14 in the study period.
Table 3. Results of gross necropsy examination
Animal I.D. |
Dose |
Gross lesion |
Group 1 |
||
01F |
2,000 mg/kg B.W. |
No significant lesion founded |
02F |
No significant lesion founded |
|
03F |
No significant lesion founded |
|
Group 2 |
||
04F |
2,000 mg/kg B.W. |
No significant lesion founded |
05F |
No significant lesion founded |
|
06F |
No significant lesion founded |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 423 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 SuperLab for M62-151100165001EN which is based on the SOP (SOPP-341) for the OECD 423 and OECD 423 (OECD, 2001). A total of 6 female Sprague-Dawley rats were orally dosed with Eversorb EP4 in three animals each group, at 2000 mg/kg b.w. for both Group 1 and Group 2 in limit test. 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.
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