N-[3-(trimethoxysilyl)propylcyclohexylamine]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 21 Aug 1998

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(trimethoxysilyl)propylcyclohexylamine]

EC Number:

221-329-8

EC Name:

N-[3-(trimethoxysilyl)propylcyclohexylamine]

Cas Number:

3068-78-8

Molecular formula:

C12H27NO3Si

IUPAC Name:

N-[3-(trimethoxysilyl)propyl]cyclohexanamine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: 203 - 219 g (males), 174 - 193 g (females)
- Fasting period before study: animals were fasted from about 16 h before to 3 - 4 h after treatment.
- Housing: animals were housed in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals.
- Diet: ssniff R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL (20% solution)
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw (main study)
500, 1000 and 2000 mg/kg bw (range finding study)

No. of animals per sex per dose:

5 (main study)
1 (range finding study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded twice daily (in the morning and afternoon) and once daily on weekends and public holidays. The animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

In a dose range finding study groups of one rat of each sex were administered the test material at dose levels of 500, 1000 and 2000 mg/kg bw via oral gavage as a 20% solution in sesame oil. The animals were observed for clinical signs of toxicity for 14 days. No mortality and no clinical signs of toxicity were recorded during the study period up to and including the highest dose tested. Body weight gain was within the expected range and no abnormalities were observed at necropsy.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality and no clinical signs of toxicity were observed

Mortality:

No mortality occurred during the study period.

Clinical signs:

No clinical signs of toxicity were observed during the study period.

Body weight:

Body weight gain was within the expected range during the study period.

Gross pathology:

Gross pathology revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute oral toxicity study according to OECD guideline 401 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed at 2000 mg/kg bw. In conclusion, a LD50 >2000 mg/kg bw was derived.