N-[3-(trimethoxysilyl)propyl]aniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Feb 1994 - 15 Dec 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(trimethoxysilyl)propyl]aniline

EC Number:

221-328-2

EC Name:

N-[3-(trimethoxysilyl)propyl]aniline

Cas Number:

3068-76-6

Molecular formula:

C12H21NO3Si

IUPAC Name:

N-[3-(trimethoxysilyl)propyl]aniline

Details on test material:

- Name of test material (as cited in study report): Dow Corning SZ-6083 Silane
- Physical state: clear colourless liquid
- Analytical purity: 97%
- Lot/batch No.: 71968NT
- Storage condition of test material: sealed container at room temperature

Test animals

Species:

rat

Strain:

other: CDF(F-344)Crl:BR VAF/PLUS

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adult
- Weight at study initiation: 144-175 g
- Fasting: 18-20 h prior to dosing until 3-4 h after dosing
- Housing: individual housing in wire-mesh cages
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5±1.5
- Humidity (%): 20-66
- 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: 1.92 mL/kg

Doses:

500, 1000, 2000 mg/kg bw (0.48, 0.96, 1.92 mL/kg)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 1, 3, and 4 h post-dose on day of appplication (day 0) and once daily thereafter. Body weights were obtained on the day before treatment, the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes (major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals)

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

809 mg/kg bw

Based on:

test mat.

95% CL:

590 - 1 109

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

704 mg/kg bw

Based on:

test mat.

95% CL:

499 - 993

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

969 mg/kg bw

Based on:

test mat.

95% CL:

831 - 1 130

Mortality:

500 mg/kg bw: 1/5 males (day 2) and 0/5 females
1000 mg/kg bw: 4/5 males (day 1-3) and 3/5 females (day 2-3)
2000 mg/kg bw: 5/5 males (day 1) and 5/5 females (day 1-2)

Clinical signs:

other: 500 mg/kg bw: Males: wet yellow urogenital staining (1/5) Females: hypoactivity (2/5), wet yellow urogenital staining (3/5) 1000 mg/kg bw: Males: hypoactivity (5/5), ataxia (4/5), ocular discharge (3/5), tremors (4/5), prostration (2/5), hypothermia (2/

Gross pathology:

Animals that were found dead:
Gastrointestinal abnormalities were observed for the majority of the rats that died during the study. Reddened kidneys and/or reddened/white renal cortico-medullary junctions were observed. Five rats had reddened or dark red adrenal glands. Hemorrhages in the thymus glands were noted. Other findings at a low incidence included an oedematous abdominal cavity and congenital accessory splenic tissue. Various external surface mattings were observed.

Animals sacrificed at end of study:
White areas in the kidneys (1/5 males, 500 mg/kg bw) and dark red lungs (1/5 females, 1000 mg/kg bw)

Any other information on results incl. tables

Table 1: Body weights of the animals in the acute oral toxicity study.

Dose group [mg/kg bw]		BW±SD [g]
		day -1	day 0	day 7	day 14
2000	male	178±9	156±7	-	-
	female	159±3	145±2	-	-
1000	male	187±2	171±3	206±0	220±0
	female	165±3	155±3	161±1	173±1
500	male	173±5	152±4	179±23	210±15
	female	165±4	149±4	161±6	168±4

Table 2: Clinical signs of the male animals in the acute oral toxicity study.

Clinical findings (number out of 5 animals)	Males
	500 mg/kg bw	1000 mg/kg bw	2000 mg/kg bw
Found dead	1	4	5
Hypoactive	0	5	5
Clear ocular discharge	0	3	5
Wet brown urogenital staining	0	1	2
Labored respiration	0	1	2
Body cool to touch	0	2	1
Ataxia	0	4	5
Prostrate	0	2	2
White frothy salivation	0	0	3
Dried brown urogenital staining	0	0	1
Convulsions	0	0	1
Tremors	0	4	2
Wet yellow urogenital staining	1	0	1
Dried red material around nose	0	1	1
Dried red material around mouth	0	2	1
Clear wet matting around mouth	0	3	1

Table 3: Clinical signs of the female animals in the acute oral toxicity study.

Clinical findings (number out of 5 animals)	Females
	500 mg/kg bw	1000 mg/kg bw	2000 mg/kg bw
Found dead	0	3	5
Hypoactive	2	5	5
Clear ocular discharge	0	4	5
Wet brown urogenital staining	0	5	3
Labored respiration	0	2	5
Body cool to touch	0	3	5
Ataxia	0	5	5
Prostrate	0	3	5
White frothy salivation	0	1	3
Dried brown urogenital staining	0	4	4
Tremors	0	1	0
Wet yellow urogenital staining	3	4	0
Dried red material around nose	0	5	0
Dried red material around mouth	0	3	3
Clear wet matting around mouth	0	1	0

Table 4: Necropsy findings of the male and female animals in the acute oral toxicity study.

Necropsy findings (number out of 5 animals)	Males			Females
	500 mg/kg bw	1000 mg/kg bw	2000 mg/kg bw	500 mg/kg bw	1000 mg/kg bw	2000 mg/kg bw
Adrenal Glands - reddened - dark red	0 0	1 1	2 0	0 0	1 0	0 0
Intestine - dark red contents	0	2	5	0	3	4
Kidneys - reddened cortico-medullary junction - reddened - white cortico-medullary junction	0   0 0	0   2 1	2   3 0	0   0 0	1   0 0	2   2 0
Lungs - mottled	0	0	4	0	0	1
Spleen - accessory	0	1	0	0	0	0
Stomach - dark red area - dark red content	0 0	1 2	1 0	0 0	1 3	3 0
Thymus gland - hemorrhagic	0	1	0	0	0	3
External surface - yellow matting - red matting - brown matting - clear matting - green matting	0 0 0 0 0	0 2 0 1 0	4 5 2 0 0	0 0 0 0 0	1 2 2 0 1	1 2 1 1 1
Abdominal cavity - oedematous	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are met, Category 4 classification required according to Regulations (EC) No 1272/2008