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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 June 1988 to 12 July 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate
EC Number:
241-165-0
EC Name:
3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate
Cas Number:
17096-07-0
Molecular formula:
C16H38O5Si4
IUPAC Name:
3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate
Test material form:
liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals, Germany
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males 118 to 136 g and females 106 to 118 g
- Fasting period before study: overnight before dosing
- Housing: Housed in group of five in stainless steel cages with wire-screen bottom and front.
- Diet (e.g. ad libitum): cereal based, open formula diet for rats and mice, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 per hour
- 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: 10.0 mL. This dose was considered to be the maximum tolerable amount of a non-aqueous liquid for single oral administration.

DOSAGE PREPARATION (if unusual): The test material was administered undiluted.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable
Doses:
10.0 mL
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication, during the first 4 hours after treatment and thereafter, at least once daily for 14 days. The individual body weights of the rats were recorded on day 0, 3, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic changes.
Statistics:
Not used.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to 9250 mg/kg bw based on density of 0.925 g/cm3
Mortality:
No deaths occurred and all rats looked healthy throughout the 14-day observation period.
Clinical signs:
None of the rats showed any clinical signs of intoxication.
Body weight:
The individual body weights of the rats on day 3, 7 and 14 did not reflect clear treatment-related growth changes.
Gross pathology:
Macroscopic examination of the rats at the termination of the study, did not reveal any treatment-related gross alteration.
Other findings:
No other findings reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study, conducted to the now deleted OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 10.0 mL/kg bw (equivalent to 9250 mg/kg bw).