Registration Dossier
Registration Dossier
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EC number: 256-032-2 | CAS number: 42978-66-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov - Dec 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Pflanzenbau und Pflanzenschutz - Rheinland Pfalz, signed on 24 Sep. 2001
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
- EC Number:
- 256-032-2
- EC Name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
- Cas Number:
- 42978-66-5
- Molecular formula:
- C15 H24 O6
- IUPAC Name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Füllinsdorf, Switzerland
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 182 g (mean body weight)
- Fasting period before study: at least 16 hours before administration, water was available ad libitum
- Housing: individually in stainless steel wire mesh cages, type DK-III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 g/100 ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
- Purity: doubly distilled water
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: without findings or clinical signs
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (2,000 mg/kg, 6 females) examined at termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 2,000 mg/kg body weight in rats.
- Executive summary:
The study was performed to assess the acute toxicity following oral administration in Wistar rats in a GLP-compliant study performed according OECD 423 guideline.
Single doses of 2,000 mg/kg body weight of test material preparations in doubly distilled water were given to two administration groups of three fasted female animals, each, by gavage in a sequential manner. After an observation period of 14 days no mortality occurred. Moreover, no clinical signs were observed. The mean body weights of the administration groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals of the 2,000 mg/kg administration group examined at the end of the observation period.
Under the conditions of this study, the median lethal dose of the test item after oral administration was found to be greater than 2,000 mg/kg body weight in rats.
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