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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:
1995-10-09 to 1995-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloropropyl)triethoxysilane
EC Number:
225-805-6
EC Name:
(3-chloropropyl)triethoxysilane
Cas Number:
5089-70-3
Molecular formula:
C9H21ClO3Si
IUPAC Name:
(3-chloropropyl)triethoxysilane
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Portage, MI
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adult (age not specified)
- Weight at study initiation: 271 to 276 g
- Fasting period before study: yes, 18-20 hours prior to dosing and returned to feed 3-4 hours after dosing
- Housing: individual suspended wire-mesh cages
- Diet : Purina Certified Rodent Chow, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: yes, for a minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21.7-22.2 °C
- Humidity: 22.6-46.7%
- Air changes (per hr): not specified
- Photoperiod: 12 hours light/ 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.05 mL/kg based on the specific gravity of 0.99 g/mL

Doses:
5000 mg/kg bw

No. of animals per sex per dose:
5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed approximately 1, 3 and 4 hours after test article administration on study day 0, then twice daily (morning and afternoon) thereafter for 14 days. Individual body weights were obtained on study days -1, 0 (initiation), 7 and 14 days (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by carbon dioxide asphyxiation)


Results and discussion

Preliminary study:
RANGE-FINDING STUDY: Prior to initiation of the main LD50 study, a range-finding study was conducted in which groups of one male and one female rat were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg bw. There were no deaths during the range-finding study. Based on these results, 5000 mg/kg bw was selected as the first level on the main study. One group of five male and five females rats was administered single doses at a level of 5000 mg/kg bw (5.05 mL/kg).
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths during the study
Clinical signs:
other: All clinical findings were noted on day 0 and/or day 1. Wet and/or dried yellow urogenital and/or ventral abdominal staining was observed for all ten animals. Soft stool was noted for six animals. One male rat had mucoid feces. There were no other clinica
Gross pathology:
There were no necropsy findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity with (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6), conducted according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, the LD50 was concluded to be greater than 5000 mg/kg bw in male and female rats.