Bis(triethoxysilylpropyl)amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Jan - 27 June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1981

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(triethoxysilylpropyl)amine

EC Number:

236-818-1

EC Name:

Bis(triethoxysilylpropyl)amine

Cas Number:

13497-18-2

Molecular formula:

C18H43NO6Si2

IUPAC Name:

bis(triethoxysilylpropyl)amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen, Germany
- Age at study initiation: 7-8 weeks (males), 9-10 weeks (females)
- Weight at study initiation: 130-178 g (males), 132-162 g (females)
- Fasting: 16 h prior to dosing
- Housing: individual housing in Makrolon cages (type II)
- Diet: ssniff R, (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 12.1 ml/kg bw

Doses:

2506, 5395, 11616 mg/kg bw (2.61, 5.62, 12.1 ml/kg bw)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (for 21 days for animal no. 6)
- Frequency of observations and weighing: The rats were observed for 4-8 h post-dose on day of appplication and once (clinical signs) or twice (mortality) daily thereafter. Body weights were obtained on the day of treatment and on day 7 and 14 (and 21 for animal 6).
- Necropsy of survivors performed: yes (major organ systems of the thoracic and abdominal cavities were examined for all animals)
- Histopathology of macroscopic findings was performed (fixation in formalin)

Statistics:

Probit analysis for LD50 calculation

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 580 mg/kg bw

Based on:

test mat.

95% CL:

3 288 - 6 325

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 657 mg/kg bw

Based on:

test mat.

95% CL:

1 333 - 7 287

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

6 106 mg/kg bw

Based on:

test mat.

95% CL:

3 167 - 12 716

Mortality:

2506 mg/kg bw: 1/5 males (day 3) and 0/5 females
5395 mg/kg bw: 4/5 males (day 1-2) and 2/5 females (day 1-4)
11616 mg/kg bw: 5/5 males (day 1-3) and 5/5 females (day 1)

Clinical signs:

other: 2506 mg/kg bw: Males: reduced locomotor activity, shivering of the head, reduction of muscle tone, nasal discharge, salivation, piloerection, cyanosis, labored breathing, abnormal gait, cavernous flanks, reduction of body weight Females: reduced locomotor

Gross pathology:

2506 mg/kg bw: mottled liver (1 animal)
5395 mg/kg bw: red coloured glandular stomach (focal erosion) and intestinal mucosa, mottled liver, pale kidney with punctual spots
11616 mg/kg bw (1 animal): red coloured glandular stomach (focal erosion) and intestinal mucosa, mottled liver, pale kidney with punctual spots

Other findings:

2506 mg/kg bw: tubular hyperplasia in 3/5 animals (in one animal: tubular dilatation, necrosis, hypertrophy, interstitial fibroplasia, secondary glomerulonephrosis and protein cylinder)
5395 mg/kg bw (1 animal): liver necrosis with liver cell hypertrophy and focal pigment deposits, necrosis in the kidney and deposits of basophile material
11616 mg/kg bw (1 animal): cell degeneration and necrosis in the liver, oval cell hyperplasia, necrosis in the kidney and deposits of basophile material

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 conducted according to OECD 401, a LD50 of 3657 mg/kg bw was derived in rats. In the low dose group 1/5 males and 0/5 females were found dead. Treatment with 5395 mg/kg bw led to 4/5 dead males and 2/5 dead females within day 1-2 and 1-4, respectively. All animals were found dead after treatment with 11616 mg/kg bw on days 1-2. In conclusion, a combined LD50 of 4580 mg/kg bw was calculated. The LD50 for males and females were 3657 and 6106 mg/kg bw, respectively.