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EC number: 217-496-1 | CAS number: 1873-88-7
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
- EC Number:
- 217-496-1
- EC Name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
- Cas Number:
- 1873-88-7
- Molecular formula:
- C7H22O2Si3
- IUPAC Name:
- 1,1,1,3,5,5,5-heptamethyltrisiloxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Switzerland
- Females: yes, nulliparous and non-pregnant
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 176.5 - 199.5 g
- Fasting period before study: yes, 16 to 18 hours (access to water was permitted, food was provided again approximately 3 hours after dosing)
- Housing: Individually in Makrolon type-3 cages with wire mesh tops and standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes, but time period not specified in report
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30-70 %
- Air changes : 10-15 air exchanges/hour
- Photoperiod: 12 hours dark/ 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Justification for choice of vehicle: The vehicle was chosen after a non-solubility trial which was performed before the study initiation date. This formulation trial is excluded from the statement of compliance. The test item prepared in corn oil was well-soluble.
- Lot/batch no. (if required): 18787208
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: The dose formulations were made shortly before dosing using a magnetic stirrer as homogenizer. The sample was shaken thoroughly before each handling. The test item was weighted into a tared glass beaker on a suitable precision balance and the vehicle (corn oil) added. Homogeneity of the test item was maintained during dose administration using a magnetic stirrer. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined daily during the acclimation period and mortality; viability and clinical signs were recorded. All animals were examined for mortality/viability and clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once (twice for mortality/viability) daily during test days 2-15. Body weights were recorded on test day 1 (prior to removal of food), on test days 1 (prior to administration) 8 and 15. All animals were necropsied and examined macroscopically.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- dissolved
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- other: Slightly to moderately ruffled fur was noted in all animals from the 1- or 5- hour reading up to test day 2 or 3, with persisting in one animal through test day 7. Slight to marked sedation was recorded in all animals from the 2-, 3- or 5-hour observation
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Other findings:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An LD50 value greater than 2000 mg/kg was determined in a reliable study conducted according to OECD 425 and in compliance with GLP.
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