Registration Dossier
Registration Dossier
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EC number: 241-867-7 | CAS number: 17928-28-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 30 2001 - July 23 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on Safety Assessment of New Cosmetics (Japan Cosmetic Industry Association, technical materials No.92, 1991
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane
- EC Number:
- 241-867-7
- EC Name:
- 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane
- Cas Number:
- 17928-28-8
- Molecular formula:
- C10H30O3Si4
- IUPAC Name:
- 2,2,4,6,6-pentamethyl-4-[(trimethylsilyl)oxy]-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD(SD)IGS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Japan Inc.
- Age at study initiation:6 weeks
- Weight at study initiation: male 193-212 g, female 131-151 g
- Fasting period before study: ca. 18 hours
- Housing: Individually housed, in stainless steel bracket cages for rats
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 or 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: According to the Guidance on Safety Assessment of New Cosmetics, 2000 mg/kg was set for the high dose group, 1000 mg/kg for the low dose group, and olive oil for the control group. - Doses:
- vehicle at 0 mg/kg, 1000 and 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality at 15, 30 minutes, 1, 3 and 6 hours after treatment on the day of treatment and thereafter once daily. Animals were weighed on the day of treatment and on days 2, 3, 4, 8, 11 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The body surface and the intracranial, intrathoracic and intra-abdominal organs were macroscopically examined. Histopathological examination was not performed because necropsy did not reveal any abnormal changes. - Statistics:
- The body weight measurements obtained in the study were averaged and standard deviation was calculated for each group, which were analysed for homogeneity of variance by F-test. Since the results showed homogenous variance, Student t-test was performed. There was no statistical significance noted.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred through the observation period in either males or females in all the groups including the control group in response to test article administration.
- Clinical signs:
- other: No clinical signs caused by the test substance were observed. Watery diarrhoea was observed in males and females in all groups, which ceased by day 2 of treatment, after which no special changes were observed.
- Gross pathology:
- There were no remarkable findings at necropsy in any group of animals.
- Other findings:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Not classified according to Regulation (EC) No 1272/2008
- Conclusions:
- An LD50 value of >2000 mg/kg bw in rats of both sexes is reported in a study equivalent to current OECD guideline, which was not GLP compliant.
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