2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 08 September 2015 and 08 October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1= Reliable without restriction o GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Cas Number:

117646-83-0

Molecular formula:

C15H28O4

IUPAC Name:

2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate

Test material form:

other: liquid

Details on test material:

Identification:
M120

Batch:
NC-5635-01

Purity:
not supplied

Physical state / Appearance:
clear colorless liquid

Expiry Date:
05 December 2015

Storage Conditions:
room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

2000mg/kg, 300mg/kg

No. of animals per sex per dose:

1 @ 300 mg/kg
5 @ 2000 mg/kg

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

RESULTS

Dose Level - 300 mg/kg

Individual clinical observations and mortality data are given in the table below.

Mortality

There was no mortality.

Clinical Observations

No signs of systemic toxicity were noted during the observation period.

Body Weight

Individual body weights and body weight changes are given in the table below.

The animal showed expected gains in body weight over the observation period.

Necropsy

Individual necropsy findings are given in the table below.

No abnormalities were noted at necropsy.

 

Dose Level - 2000 mg/kg

Based on the results at a dose level of 300 mg/kg, a dose level of 2000 mg/kg body weight was investigated.

Individual clinical observations and mortality data are given in the table below.

Mortality

There were no deaths..

Clinical Observations

Signs of systemic toxicity noted in the initial treated animal during the day of dosing were hunched posture, ataxia, pilo-erection and tiptoe gait. There were no signs of systemic toxicity noted in the additional four treated animals.

Body Weight

Individual body weights and body weight changes are given in the table below.

All animals showed expected gains in body weight over the observation period.

Necropsy

Individual necropsy findings are given in the table below.

No abnormalities were noted at necropsy.

 

Table of Individual Clinical Observations and Mortality Data. Body Weights and Body Weight Changes, and Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)														Body Weight (g) at Day			Body Weight Gain (g) During Week		Time of Death	Macroscopic Observations
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14	0	7	14	1	2
300	1-0 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	171	190	199	19	9	Killed Day 14	No abnormalities detected
2000	2-0 female	0	0	HA	HAPWt	0	0	0	0	0	0	0	0	0	0	0	0	0	0	187	202	218	15	16	Killed Day 14	No abnormalities detected
2000	3-0 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	160	179	191	19	12	Killed Day 14	No abnormalities detected
2000	3-1 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	151	166	180	15	14	Killed Day 14	No abnormalities detected
2000	3-2 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	170	183	197	13	14	Killed Day 14	No abnormalities detected
2000	3-3 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	171	179	189	8	10	Killed Day 14	No abnormalities detected

where:

0 = No signs of systemic toxicity

H = Hunched posture

A = Ataxia

P = Pilo-erection

Wt = Tiptoe gait

CONCLUSION

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Category 5).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight and thus not classified for CLP. (Globally Harmonized Classification System - Category 5).