Registration Dossier
Registration Dossier
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EC number: 500-085-9 | CAS number: 35176-06-8 1 - 6.5 moles propoxylated
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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-Iminodiethanol, propoxylated
- EC Number:
- 500-085-9
- EC Name:
- 2,2'-Iminodiethanol, propoxylated
- Cas Number:
- 35176-06-8
- Molecular formula:
- C4H11O2N(C3H6O)n; n = 1 – 6.5
- IUPAC Name:
- 2,2’-Iminodiethanol, propoxylated
- Reference substance name:
- 500-06-8
- IUPAC Name:
- 500-06-8
- Details on test material:
- - Physical state: liqiud
- Content: > 99%
- Molar mass: 320 g/mol
- Stability under test conditions: the analytical data verify that the test item formulations are stable at room temperature for at least 2 hours
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Horst, Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 152 - 173 g
- Housing: Groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals per group
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No particular findings
Applicant's summary and conclusion
- Conclusions:
- According to OECD guideline 423 the LD50 cut off is >= 5000 mg/kg bw. According to UN GHS the test item is unclassified. So itis regarded as non-toxic.
- Executive summary:
The acute oral median lethal dose (LD50) of the test material in the female Wistar rat was > 2000 mg/kg bw with regard to a study according to OECD TG 423. A dose of 2000 mg/kg bw was tolerated without mortalities, clinic signs, effects on weight gain and gross pathological findings.
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