Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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.