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EC number: 230-241-9 | CAS number: 6976-93-8
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:
- 1 997
- 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
- 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
Constituent 1
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
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