Registration Dossier
Registration Dossier
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EC number: 827-772-9 | CAS number: 20650-07-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (3-methoxypropyl)dimethylamine
- EC Number:
- 827-772-9
- Cas Number:
- 20650-07-1
- Molecular formula:
- C6H15NO
- IUPAC Name:
- (3-methoxypropyl)dimethylamine
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000, 300 and 300 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Fasted Wistar rats (3 females/set) (10 to 11 weeks) were given a single oral dose of DMMOPA Multifunctional Etheramine Additive at a dose of 2000 (set I) and 300 (set II and III) mg/kg body weight and surviving rats were observed for 14 days.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LDLo
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All set I rats in treated with 2000 mg/kg body weight were found dead within 1 hour after treatment. No mortality was observed in set II rats treated with 300 mg/kg body weight. One mortality was observed in set III rats within 4 hours after treatment with 300 mg/kg body weight.
- Clinical signs:
- lethargy (hypoactivity)
- observations of tremors
- Body weight:
- other body weight observations
- Remarks:
- Normal body weight gain was observed in all surviving rats.
- Gross pathology:
- External examination of the found dead and terminally sacrificed rats did not reveal any abnormality. Internal examination of found dead rats revealed minimal to mild red discoloration of the stomach at 2000 and 300 mg/kg body weight and of the intestine at 2000 mg/kg body weight. Internal examination of terminally sacrificed rats did not reveal any abnormality.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
In a study according to OECD 423 Guideline, the acute oral median lethal dose (LD50 cut-off value) of DMMOPA Multifunctional Etheramine Additive in Wistar rats was 500 mg/kg body weight.
Based on this result, the classification of DMMOPA Multifunctional Etheramine Additive according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2021) is Acute Toxicity, Oral - Category 4.
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