Registration Dossier
Registration Dossier
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EC number: 923-108-8 | CAS number: -
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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
- EC Number:
- 923-108-8
- IUPAC Name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, AD Horst, Netherlands
- Age at study initiation: 8 -1 2 weeks
- Weight at study initiation: 168 - 215 g
- Fasting period before study: 16 - 24
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- none
- Body weight:
- no effects on weight gain
- Gross pathology:
- no findings
- Other findings:
- none
Any other information on results incl. tables
| Dose (mg/kg bw) | Toxicological results | Onset and duration of signs | Onset of mortality |
| (1st) 2000 | 0 / 3/ 3 | --- | --- |
| (2nd) 2000 | 0 / 3/ 3 | --- | --- |
Toxicological results:
number of dead animals / number of animals with signs of toxicity after treatment / number of animals treated
Applicant's summary and conclusion
- Executive summary:
A single oral dose of 2000 mg/kg bw was tolerated withouth mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the LD50 cut-off for the test item is 5000 mg/kg bw.
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