Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
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
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 176.5-199.5
- Fasting period before study:
- 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 (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
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 - 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
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- 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 up to 5 hours post-dose or test days 2 or 3. Two animals showed slightly poor coordination on test day 2 only, while two other animals showed slight to markedly or slightly to moderately poor coordination from 5 hours post-dose until test day 2. Hunched posture was observed in four animals at the 1-hour reading and persisted through the 5-hour evaluation in one animal and through test day 2 in three animals. Ventral recumbency was noted in one animal on test day 2.
- Body weight:
- The body weight of animals was within the range commonly recorded for this strain and age.
- 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 of >2000 mg/kg was determined in a reliable study conducted in compliance with GLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
