2-methoxyethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-03-17 to 1997-04-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxyethyl methacrylate

EC Number:

230-241-9

EC Name:

2-methoxyethyl methacrylate

Cas Number:

6976-93-8

Molecular formula:

C7H12O3

IUPAC Name:

2-methoxyethyl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Acryester MT

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl:CD BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: main study, 226-239 g (males), 200-219 g (females)
- Fasting period before study: yes, overnight + 3-5 h after dosing
- Housing: in groups of up to 5 in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 44-53
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.04 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded on days 0, 7, 14; clinical signs: 1/2, 1, 2, 4 h after dosing, once daily thereafter
- Necropsy of survivors performed: yes

Dose selection based on the results of a range finding study:
2000 mg/kg bw of the test substance was administered to 1 male and 1 female rat
Animals were observed for clinical signs 1/2, 1, 2, 4 h after dosing, once daily thereafter for 5 days

Results and discussion

Preliminary study:

There were no deaths in the range-findng study (dose level 2000 mg/kg bw). Clinical signs of toxicity noted in both animals 0.5 hour to one day after dosing were hunched posture, lethargy, pilo-erection, ataxia and decreased respiratory rate with additional signs of red/brown staining around the mouth and an isolated incident of increased salivation in the male. Animals recovered two days after dosing.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mortality: 0/10

Mortality:

There were no deaths

Clinical signs:

other: 3/5 males and 3/5 females showed no clinical signs at all. Common signs of systemic toxicity noted in 2/5 males and 2/5 females were hunched posture, lethargy and piloerection with additional signs of decreased respiratory rate 4 h to 2 d after dosing. An

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of MTMA in rat is >2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 (adopted 24 February 1987), groups of fasted, 8 to 12 weeks old Sprague-Dawley CD (Crl:CD BR) rats, 5/sex were given a single oral dose of MTMA (no information on purity) 2000 mg/kg bw and observed for 14 days.

No animal died during the study. 3/5 males and 3/5 females showed no clinical signs. Common signs of systemic toxicity noted in 2/5 males and 2/5 females were hunched posture, lethargy and piloerection with additional signs of decreased respiratory rate 4 h to 2 d after dosing. Animals had recovered 2 to 3 days after dosing. 

All animals showed the expected body weight gain during the study, except for one female which showed a loss in bodyweight during the second week. No abnormalities were noted at necropsy.

Oral LD50 in males/females (rat) > 2000 mg/kg bw