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Registration Dossier
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EC number: 245-659-7 | CAS number: 23432-62-4
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 June - 23 July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 2001
- Deviations:
- yes
- Remarks:
- 200 mg/kg bw instead of 300 mg/kg bw was used as starting dose.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Methyl [3-(trimethoxysilyl)propyl]carbamate
- EC Number:
- 245-659-7
- EC Name:
- Methyl [3-(trimethoxysilyl)propyl]carbamate
- Cas Number:
- 23432-62-4
- Molecular formula:
- C8H19NO5Si
- IUPAC Name:
- methyl N-[3-(trimethoxysilyl)propyl]carbamate
- Details on test material:
- - Name of test material (as cited in study report): Silan 449003 VP (SLM 449003)
- Physical state: colourless-yellowish liquid
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdBrlHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data available
- Weight at study initiation: 143 - 154 g (step 1), 142 - 152 g (step 2), 151 - 160 g (step 3), 143 - 162 g (step 4)
- Housing: animals were kept in Macrolon cages on Altromin saw fiber bedding
- Fasting period before study: yes (overnight before dosing and 3-4 h after dosing)
- Diet: Altromin 1324 maintenance diet for rats and mice (totally-pathogen-free), ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, adequate acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg bw (step 1-4)
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw (step 1-4) - Doses:
- 200, 2000 mg/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: a careful clinical observation was made twice a day on the day of dosing and once a day thereafter, body weights were determined prior to substance application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs of toxicity were observed.
- Gross pathology:
- Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In an acute oral toxicity study according to OECD guideline 423 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed up to 2000 mg/kg bw. In conclusion, a LD50 cut-off value of 5000 mg/kg bw was derived.
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