2-(2-methoxyethoxy)ethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-methoxyethoxy)ethyl methacrylate

EC Number:

256-190-2

EC Name:

2-(2-methoxyethoxy)ethyl methacrylate

Cas Number:

45103-58-0

Molecular formula:

C9H16O4

IUPAC Name:

2-(2-methoxyethoxy)ethyl 2-methylprop-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Female (nulliparous and non-pregnant),
Species/Strain: Rat/Sprague-Dawley
Age: 8 to 12 weeks at experimental start Weight: +/-20% of the mean initial weight of previously dosed animals for each sex.
Species Justification:The rat is the system of choice because it has been shown to be sensitive to toxic effects of a variety of chemicals and it is a standard animal model for the acute oral toxicity test.
Number of Animals Justification: The Up and Down Procedure permits the calculation of the LD50 and confidence limits using the smallest number of animals possible.


Animals are individually housed in suspended wire-bottom cages that conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals (National Research Council). Absorbent paper bedding, placed beneath the cage, was changed at least three times per week. The animal room, reserved exclusively for rats, is temperature controlled and has a 12-hour light/dark cycle. Temperature and humidity was continuously recorded using automatic recording devices.

Fresh PMI Rat Chow (Diet #5012) was available ad libitum except for 16 to 20 hours prior to dosing. Water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity.

Doses:

Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal survived, four additional females were dosed at 2000 mg/kg.

No. of animals per sex per dose:

1 inital and then four additional animals

Control animals:

no

Details on study design:

One animal is dosed at 2000 mg/kg. If the first animal dies, conduct the main test to determine the LD50. If the first animal dosed at 2000 mg/kg survives, four animals will be sequentially dosed (a total of five animals are tested). If three animals die, the limit test is terminated and main test is performed. The rats were fasted 16 to 20 hours prior to test article administration.
Animals will be observed at 15 (±5) minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Abnormal physical signs including wetness and red staining of the nose/mouth area, piloerection and chromorhinorrhea were observed.

Body weight:

All five animals gained body weight by study termination. One animal lost weight from Day 7 to Day 14.

Gross pathology:

The gross necropsy revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an oral acute toxicity study according to the current EPA Health Effects Test Guidelines, OCSPP 870.1100, and OECD TG 425, the oral LD50 of 2-(2-methoxyethoxy)ethyl methacrylate is greater than 2000 mg/kg body weight in female Sprague Dawley rats.

Executive summary:

In order to investigate the potential for acute toxicity by the oral route according to the current EPA Health Effects Test Guidelines, OCSPP 870.1100, and OECD TG 425 following GLP conditions, a single female Sprague Dawley rat was dosed orally with  2-(2-methoxyethoxy)ethyl methacrylate at a dose level of 2000 mg/kg.  Since the animal survived, four additional females were dosed at 2000 mg/kg.  The rats were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects.  All animals were observed twice daily for mortality on Day 1 to Day 14.  Body weights were recorded pre-test, weekly, and at termination.  All animals were examined for gross pathology.  

All five animals gained body weight by study termination.  One animal lost weight from Day 7 to Day 14. The gross necropsy revealed no observable abnormalities.

The oral LD50 of 2-(2-methoxyethoxy)ethyl methacrylate is greater than 2000 mg/kg of body weight in female rats.