Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-07-13 to 2011-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

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

Constituent 1
Chemical structure
Reference substance name:
Octaphenylcyclotetrasiloxane
EC Number:
208-904-9
EC Name:
Octaphenylcyclotetrasiloxane
Cas Number:
546-56-5
Molecular formula:
C48H40O4Si4
IUPAC Name:
octaphenyl-1,3,5,7,2,4,6,8-tetraoxatetrasilocane
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Orient BIO Co., Korea
- Age at study initiation: 9 weeks old
- Weight at study initiation: 188.0 - 215.0 g (Step 1), 222.0 - 234.7 g (Step 2)
- Fasting period before study: food was removed for 1 day before administration, water was supplied
- Housing: 2 -3 animals in stainless steel cages
- Diet: pellet diet for rat, ad libitum
- Water: filtered and UV irradiated water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 10-15/ hour
- 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: 2000 mg/mL in corn oil for step 1 and 2
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Following administration of 2000 mg/kg bw in step 1, no deaths occurred (Limit test).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Step 1: 3 females
Step 2: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were examined at 4 hours post administration, then daily during the 14-day study period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and macroscopic examination at necropsy

Results and discussion

Effect levels
Sex:
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:
No clinical signs of toxicity were noted in any of the animals.
Body weight:
Expected body weight gain was observed in all of the test animals.
Gross pathology:
No macroscopic abnormalities were noted at necropsy in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study the reported LD50 value for octaphenylcyclotetrasiloxane was >2000 mg/kg bw.