Registration Dossier
Registration Dossier
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EC number: 467-100-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 June 2006 - 14 july 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- -
- EC Number:
- 467-100-8
- EC Name:
- -
- Cas Number:
- 116229-43-7
- Molecular formula:
- C15H33NO3Si
- IUPAC Name:
- (E)-(4-methylpentan-2-ylidene)[3-(triethoxysilyl)propyl]amine
- Test material form:
- liquid
- Details on test material:
- Batch/Lot: 630401
Purity: 92.92%
Constituent 1
- Specific details on test material used for the study:
- Batch/Lot: 630401
Purity: 92.92%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, germany.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9-12 weeks old
- Fasting period before study: overnight
- Housing: 3 animal per cage, Macrolon cages (MIY type, height 18 cm.)
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 */- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 300 mg/kg bw (0.323 ml/kg bw)
2000 mg/kg bw (2.15 ml/kg bw) - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observation, weighing on day 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 1 000 mg/kg bw
- Mortality:
- Two females dosed at 2000 mg/kg were found dead within two hours post-treatment. No further mortality occurred.
- Clinical signs:
- other: Dose level Clinical signs 300 mg/kg Hunched posture 2000 mg/kg hunched posture and salivation the surviving animals had recovered by day 2 (300 mg/kg) and 5 (2000 mg/kg).
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
See attached file for data tables.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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