Registration Dossier
Registration Dossier
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EC number: 254-075-1 | CAS number: 38668-48-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.02.2001 - 10.04.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-(p-tolylimino)dipropan-2-ol
- EC Number:
- 254-075-1
- EC Name:
- 1,1'-(p-tolylimino)dipropan-2-ol
- Cas Number:
- 38668-48-3
- Molecular formula:
- C13H21NO2
- IUPAC Name:
- 1,1'-(p-tolylimino)dipropan-2-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 120 to 150 grams
- Fasting period before study: overnight fast prior to dosing
- Housing: polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 25, 200, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males (2000 and 200 mg/kg bw)
3 males and females (25 mg/kg bw) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Body weight: at allocation to the study (day -1), prior the dosing (day 1) and on day 8 and 15
- Clinical signs: 1,2 and 4 hours after dosing and daily thereafter for a total of 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 25 - < 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 25 mg/kg bw: no death
200 mg/kg bw: 2/3 males within 1 hour after dosing
2000 mg/kg bw: 3/3 males within 1 hour after dosing - Clinical signs:
- other: 25 mg/kg bw : no clinical signs were observed 200 mg/kg bw: 2/3 males showed convulsions and pronation approximately 5 minutes after dosing 2000 mg/kg bw: 3/3 males showed convulsions appproximately 1 minute after dosing
- Gross pathology:
- Abnormal content (yellow or pale mucoid or creamy material) in the stomach and in the jejunum of the early decedent male animals.
Skin/fur staining around the perioral/perinasal region in early decedent male animals.
Applicant's summary and conclusion
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