N-[(triethoxysilyl)methyl]cyclohexylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 Feb, 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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 rats (Full-Barrier)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Body weight at the commencement of the study: male 194 - 216 g and female 194 - 200 g. 5 male and 5 female animals were used.
- The animals were derived from a controlled full barrier maintained breeding system (SPF).
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Husbandry
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
Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Approximately 24 hours before the test, fur was removed from the dorsal area ofthe trunk by clipping.
Not less than 10% ofthe body surface was cleared for the application.
Prior to the first application a detailed clinical observation was made of all animals.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied to the patch first, and then applied to the skin. Test item was held in contact with the skin with a gauze-dressing and nonirritating tape and was fixed with an additional dressing in a suitable manner.

Duration of exposure:

Test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure, residual test item was removed by using tap water.

Doses:

The test item was applied at a single dose (2000 mglkg bw) by applying uniformly over an area which was approx. 10% ofthe total body surface.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed for 14 days after dosing.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period. The skin at the application site showed no changes

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in any animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this dermal toxicity test it can be stated that the test item did not show relevant toxicity under the conditions of the test.
The LDso was determined to be > 2000 mg/kg bw.

Executive summary:

A acute dermal toxicity test according to OECD Guideline No. 402 was performed with the test item.

Considering the reported data of this dermal toxicity test it can be stated that the test item did not show relevant toxicity under the conditions of the test.

The LDso was determined to be > 2000 mg/kg bw.