Registration Dossier
Registration Dossier
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EC number: 700-340-6 | CAS number: 76524-94-2
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom (2011)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]formamide
- EC Number:
- 700-340-6
- Cas Number:
- 76524-94-2
- Molecular formula:
- C10H23NO4Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]formamide
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Y-15864
- Physical state: pale yellow liquid
- Analytical purity: 97.5% – 99.5%
- Lot/batch No.: TER00010-68-31
- Expiration date of the lot/batch: 12.09.2012
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar (RccHanTM:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 156 - 187 g
- Fasting period before study: overnight and 3 - 4 hours before dosing
- Housing: groups up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg: 30mg/mL; 2000 mg/kg: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 (300 mg/kg bw)
5 (2000 mg/kg bw) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations 0.5, 1, 2 and 4 h after dosing, then daily; body weights on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: morbidity and mortality twice daily
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw: No mortalities occurd
2000 mg/kg bw: No mortalities occurd - Clinical signs:
- other: 300 mg/kg bw: No clinical signs observed 2000 mg/kg bw: ataxia, hunched posture, lethargy and ptosis; animal appeared normal for four hours or one day after dosing
- Gross pathology:
- No abnormalities were noted
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
A high reliable study according to OECD guideline 420 was performed with 5 female Wistar rats under GLP conditions. The animals were treated with 2000 mg/kg bw of the test substance by gavage in a single dose. Clinical signs like ataxia, hunched posture, lethargy and ptosis were observed. The animals appeared normal for four hours or one day after dosing and no deaths occured. The LD50 was therefore set to be > 2000 mg/kg bw.
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