Methyl 2-[(2-methylundecylidene)amino]benzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study will be available 08/2018

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted: 17th December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2-[(2-methylundecylidene)amino]benzoate

EC Number:

267-104-8

EC Name:

Methyl 2-[(2-methylundecylidene)amino]benzoate

Cas Number:

67800-80-0

Molecular formula:

C20H31NO2

IUPAC Name:

methyl 2-[(2-methylundecylidene)amino]benzoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Wistar rats
Source: Slovak Academy of Sciences Dobrá Voda, Slovak Republic
Number and Sex of Animals: 6 females
Age at First Dose: 8-9 weeks; female animals were non-pregnant and nulliparous
Animal Health: Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central air- conditioning. The average room temperature was maintained within the range of 22.31 ± 0.15 °C, relative humidity within 53.60 ± 2.89 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted 10-12 h prior to dosing (food but not water was withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat. (total fraction)

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed during the study.

Clinical signs:

other: During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Table 4 Necropsy Results

Sex Dose ID Result Sex Dose ID Result

♀
2000 mg/kg 1 no finding
♀
2000 mg/kg 4 no finding
2 no finding 5 no finding
3 no finding 6 no finding

Other findings:

All test animals were subjected to gross necropsy and the results were recorded for each animal. Examinations included: external body surface and orifices, the appearance of tissues and organs in the thoracic cavity (trachea, esophagus, heart, aorta, lungs with main stem bronchi, thymus, tracheobronchial lymph node) and in the abdominal cavity (liver, spleen, adrenal glands, kidneys, ovaries, uterus including cervix, urinary bladder, small intestine, large intestine, pancreas, stomach, mesenteric lymph nodes).

Any other information on results incl. tables

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1 - Initial	Week 2 - Initial	Week 2 - Week 1
♀	2000 mg/kg	1	170	205	212	35	42	7
		2	171	217	232	46	61	15
		3	172	216	228	44	56	12
		4	176	201	208	25	32	7
		5	176	200	207	24	31	7
		6	178	209	219	31	41	10

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item “Methyl 2-[(2-methylundecylidene)amino]benzoate” is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “Methyl 2-[(2- methylundecylidene)amino]benzoate” is according to GHS criteria classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item “Methyl 2-[(2- methylundecylidene)amino]benzoate” when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item administered to6 females at a limit dose did not cause death. The body weights of all animals increased during the study. No body weight losses were observed between the first and second week after administration. During necropsy, no macroscopic findings wereobserved.

The LD50of the test item “Methyl 2-[(2-methylundecylidene)amino]benzoate” is greater than 2000mg/kg body weight after single oral administration to Wistar rats.

Based onAnnex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423it can be concluded that the test item “Methyl 2-[(2- methylundecylidene)amino]benzoate” is according to GHS criteria classified in Category5/Unclassified with a LD50cut off value equal to or greater than 5000 mg/kg body weight, aftersingle oral administration to Wistar rats.