Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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 (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(2,4,4-trimethylpentyl)silane
EC Number:
252-558-1
EC Name:
Triethoxy(2,4,4-trimethylpentyl)silane
Cas Number:
35435-21-3
Molecular formula:
C14H32O3Si
IUPAC Name:
triethoxy(2,4,4-trimethylpentyl)silane
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Biological Research Laboratories.
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Males: 206-216 g. Females: 171-190 g.
- Fasting period before study: Yes, overnight.
- Housing: Groups of three in Makrolon type-4 cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 40-66
- 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: None given


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None given.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs: four times per day on the day of treatment, and once daily thereafter. Body weights: Pre-administration and on Days 8 and 15.
- Necropsy of survivors performed: yes, on day 15 after observations.
- Other examinations performed: Macroscopic examination.
Statistics:
No statistical analysis as no deaths occurred.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred.
Mortality:
No deaths occurred.
Clinical signs:
There were no clinical signs.
Body weight:
The body weights were in the expected range.
Gross pathology:
No abnormal findings.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 for triethoxy(2,4,4-trimethylpentyl)silane was concluded to be >2000 mg/kg bw. No deaths occurred up to the highest dose tested.