Registration Dossier
Registration Dossier
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EC number: 260-754-3 | CAS number: 57472-68-1
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: comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- doses up to 5000 mg/kg bw were tested
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Oxybis(methyl-2,1-ethanediyl) diacrylate
- EC Number:
- 260-754-3
- EC Name:
- Oxybis(methyl-2,1-ethanediyl) diacrylate
- Cas Number:
- 57472-68-1
- Molecular formula:
- C12H18O5
- IUPAC Name:
- oxydipropane-1,2-diyl bisacrylate
- Details on test material:
- - Name of test material (as cited in study report): Dipropylenglykoldiacrylat
- Physical state: liquid
- Analytical purity: product characterization is included in the raw data
- Lot/batch No.: Partie 2/87
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Weight at study initiation: mean males: 179 g; mean females: 182 g
- Fasting period before study: 16 hours, water ad libitum
- Housing: 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
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:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 8.25, 14.70, 21.50, 38.30, 50 (w/v)
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: aqueous formulation correspons to the physiological medium
MAXIMUM DOSE VOLUME APPLIED:
The administered volume was always 10 ml/kg
- Doses:
- 825, 1470, 2150, 3830, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: start of the study, day 5, day 7 and day 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Probit Analysis according to Finney, Test for homogeneity, chi square test
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 530 mg/kg bw
- 95% CL:
- > 2 550 - < 4 730
- Remarks on result:
- other: slope factor: 1.57
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 270 mg/kg bw
- Remarks on result:
- other: slope factor: 1.82
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 810 mg/kg bw
- Remarks on result:
- other: slope factor: 1.58
- Mortality:
- no mortalities at 825 mg/kg bw; 0/5 males and 1/5 females died at the 1470 mg/kg dose level; 1/5 males and 0/5 females died at the 2150 mg/kg dose level; 2/5 males and all females died at the 3830 mg/kg dose level; 3/5 males and 4/5 females died at the 5000 mg/kg dose level
- Clinical signs:
- other: no symptoms were observed at the 825 mg/kg dose level for either males or females; males of the 1470 mg/kg dose level exhibited dyspnea, apathy, staggering, piloerection and a poor general state on day 7; females of the 1470 mg/kg dose level exhibited dys
- Gross pathology:
- animals of the 825 mg/kg dose group: no pathological findings noted
animals that died (males and females): General congestion. Stomach: mucosa of glandular stomach reddened . Two animals which died 6/7 days after
administration of substance (1470, 2150 mg/kg) had intraabdominal adhesions. In addition one of them had hemorrhagic peritonitis.
Sacrificed animals (males and females): at doses of 1470 to 5000 mg/kg: Intraabdominal adhesions; Mucosa of forestomach with widespread hyperplasia.
Applicant's summary and conclusion
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