Registration Dossier
Registration Dossier
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EC number: 225-383-3 | CAS number: 4813-57-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-15 to 2012-06-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- (EC) No 440/2008 of 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay, Heidelberg
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Propenoic acid, C16-18-alkyl esters
- EC Number:
- 292-060-1
- EC Name:
- 2-Propenoic acid, C16-18-alkyl esters
- Cas Number:
- 90530-21-5
- IUPAC Name:
- 2-Propenoic acid, C16-18-alkyl esters
- Test material form:
- other: Liquid to solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 163 - 201 g
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10
- Photoperiod: 12 h night/12 h day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females (1 Administration)
3 females (2 Administration) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- 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.
- Remarks on result:
- other: no mortality occured
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were observed
- Gross pathology:
- There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.
Any other information on results incl. tables
Under the conditions of this study the median lethal dose of Stearylacrylate, Synative MM SA, Stearyl 1618 after oral administration was found to be greater than 2000 mg/kg bw in rats.
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 substance after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the undiluted test item were administered to two test grooups of three fasted Wistar rats by gavage.
The following test substance-related clinical observations were recorded:
2000 mg/kg:
- No mortality occured.
- No clinical signs were observed.
- The mean body weight of the surviving animals incresed within the normal range throughout the study period. Except one animal of the first test group, which showed stagnation of body weight during the second post-exposure week.
- There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.
The acute oral LD50 was calculated to be > 2000 mg/kg bw.
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