Registration Dossier
Registration Dossier
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EC number: 253-973-0 | CAS number: 38495-30-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-08-01 to 1986-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
- EC Number:
- 253-973-0
- EC Name:
- 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
- Cas Number:
- 38495-30-6
- Molecular formula:
- C16H36O8Si
- IUPAC Name:
- 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane
- Test material form:
- other: liquid
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: Interfauna (UK) Limited
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: males 125 -152 g, females 127 - 147 g
- Fasting period before study: overnight before dosing and 2 hours after dosing
- Housing: in polypropylene cages
- Diet: Rat and Mouse Expanded Diet No. 1, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 60-70 %
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.94 ml/kg
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made at 1 and 4 hours after administration, and then daily for 14 days; body weights were recorded on the day of the treatment (day 0), and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- No statistics were used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the 14-day study period.
- Clinical signs:
- other: Hunched posture, pilo-erection and decreased respiratory rate were observed in all treated animals at 1 and 4 hours post-administration. Additionally, lethargy was noted in 5 out of 10 animals, as well as ataxia in 4 out of 10 animals at 1 and 4 hours aft
- Gross pathology:
- No abnormalities were observed at necropsy at the end of the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the acute oral toxicity study, conducted according to OECD TG 401, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported for 12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane.
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