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EC number: 222-222-9 | CAS number: 3390-61-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-10 to 2002-08-09
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane
- EC Number:
- 222-222-9
- EC Name:
- 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane
- Cas Number:
- 3390-61-2
- Molecular formula:
- C33H34O2Si3
- IUPAC Name:
- 4-methyl-2,2,4,6,6-pentaphenyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: males - 42 days; females - 50 days
- Weight at study initiation: males - 219 - 244 g; females - 193 - 200 g
- Fasting period before study: none
- Housing: in groups of 2-3 in MAKROLON cages
- Diet: Standard diet for rats and mice ssniff R/M-H V1530, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55 % +/- 15 %
- 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: 1.87 mL/ kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the dose used was selected from a series of defined dose levels - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6, 24 hours after administration. Body weights were recorded before administration and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes. At the end of the study period all the animals were sacrificed, dissected and inspected macroscopically.
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed at least once a day until all the symptoms subsided, thereafter each working day. Attention was also paid to tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- No statistics were used in the study.
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 occurred during the 14-day study period.
- Clinical signs:
- other: No clinical signs of systemic toxicity were noted during the 14-day study period.
- Gross pathology:
- No macroscopic abnormalities were observed at post mortem examination.
- Other findings:
- There were no other findings in the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported.
- Executive summary:
In the acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported.
A single dose of 2000 mg/kg bw of undiluted test substance was administered orally to 3 male and 3 female rats. Observations were made before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6, 24 hours after administration. Body weights were recorded before administration and thereafter in weekly intervals up to the end of the 14 -day study. At the end of the study period all the animals were sacrificed, dissected and inspected macroscopically.
No mortality occurred during the 14 -day study period. No signs of systemic toxicity were noted. No macroscopic abnormalities were observed at necropsy.
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