Registration Dossier
Registration Dossier
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EC number: 221-499-3 | CAS number: 3121-61-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Only animals who died during the observation period were necropsied. Lack of data on test substance (no analytical purity).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only dead animals were necropsied; no histopathology
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-methoxyethyl acrylate
- EC Number:
- 221-499-3
- EC Name:
- 2-methoxyethyl acrylate
- Cas Number:
- 3121-61-7
- Molecular formula:
- C6H10O3
- IUPAC Name:
- 2-methoxyethyl acrylate
- Details on test material:
- - Name of test material (as cited in study report): Sipomer MCA
- Physical state: clear liquid
- Analytical purity: no data
- Lot No.: E169H8
- Density: 1.01 g/cm³
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 h
- Housing: during the test period the animals were housed individually in stainless steel wire bottomed cages.
- Diet: Fisher Rat Chow; ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-22.2
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- DOSAGE PREPARATION: 1.0 mL test material was diluted to 10.0 mL with water.
MAXIMUM DOSE VOLUME APPLIED: 0.6 mL/kg bw - Doses:
- 0.25 mL/kg bw corresponding to 252.5 mg/kg bw
0.35 mL/kg bw corresponding to 353.5 mg/kg bw
0.50 mL/kg bw corresponding to 505.0 mg/kg bw
0.55 mL/kg bw corresponding to 555.5 mg/kg bw
0.60 mL/kg bw corresponding to 606.0 mg/kg bw
Based on the density of Sipomer MCA: 1.01 g/cm³ - 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: daily
- Frequency of weighing: after fasting; surviving animals were weighed at the end of the 14-day observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs - Statistics:
- The defined oral LD50 was calculated by the Litchfield-Wilcoxin method of Probit Analysis (J. Pharmacology and Experimental Therapeutics 96: 99-115, 1949).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 404 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 343.4 - 464.6
- Mortality:
- 252.5 mg/kg bw: no animals died
353.5 mg/kg bw: 2 males and 2 females died
505.0 mg/kg bw: 2 males and 3 females died
555.5 mg/kg bw: 4 males and 4 females died
606.0 mg/kg bw: 5 males and 5 females died - Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- Necropsy revealed pulmonary haemorrhages (only dead animals were necropsied). Incidences:
353.5 mg/kg bw: 1 female
505.0 mg/kg bw: 1 male
555.5 mg/kg bw: 4 males, 2 females
606.0 mg/kg bw: 2 males, 1 females
Any other information on results incl. tables
Table 1. Acute oral toxicity.
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
252.5 |
0/0/0 |
--- |
--- |
0 |
353.5 |
2/0/5 |
--- |
Day 2 |
40 |
505.0 |
2/0/5 |
--- |
Day 3 - Day 4 |
40 |
555.5 |
4/0/5 |
--- |
Day 2 |
80 |
606.0 |
5/0/5 |
--- |
Day 2 |
100 |
Females |
||||
252.5 |
0/0/0 |
--- |
--- |
0 |
353.5 |
2/0/5 |
--- |
Day 3 |
40 |
505.0 |
3/0/5 |
--- |
Day 2 - Day 3 |
60 |
555.5 |
4/0/5 |
--- |
Day 2 - Day 3 |
80 |
606.0 |
5/0/5 |
--- |
Day 2- Day 4 |
100 |
LD50 = 404 mg/kg bw |
||||
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals usedApplicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Oral 4, H302
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