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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24 February 1987
Deviations:
no
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

Constituent 1
Chemical structure
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