N-[(triethoxysilyl)methyl]cyclohexylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 12 - March 26, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted December 17, 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

454-780-6

EC Name:

-

Cas Number:

27445-54-1

Molecular formula:

Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si

IUPAC Name:

Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: HsdBrlHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: Rarlan Winkelmann GmbR, D-33178 Borchen
Step 1: Body weight at the commencement of the study: 140 - 153 g;
Step 2: Body weight at the commencement of the study: 149 - 150 g;
HOUSING AND ENVIRONMENTAL CONDITIONS
The animals were barrier maintained (semi-barrier) in an air conditioned room
Temperature: 22 ± 3°C
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
The animals were kept in Macrolon cages on Altromin saw fiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item was administered according to bodyweight at a volume of 10 mL/kg bw.

Doses:

The starting dose (step 1 and step 2) was selected to be 2000 mg/kg body weight. According to the acute toxic class method regime no further testing was required.

No. of animals per sex per dose:

Three female animals were used for each step.

Control animals:

no

Details on study design:

- Observation: Animals were observed for 14 days after dosing
- Clinical Examination: A careful clinical examination was made several times on the day of dosing. Part of this were at least three observations within the first four hours postdose. Animals were observed once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The dosage of 2000 mg/kg bw caused no compound-related mortality in any animals of step 1 and 2 within 14 days post-dose.

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathologicalchanges were found in any animals of step 1 and 2.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item is not harmful after ingestion under the coniditions of the test.

Executive summary:

The acute toxic class method according to OECD Guideline No. 423 was performed with the test item. Considering the reported data of this toxicity test it can be stated that the test item is not harmful after ingestion under the coniditions of the test.