Trimethoxypropylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Feb 1987 to 12 March 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Non GLP. No data on purity or stability. The females were tested at 2 doses, whereas at least 3 are recommended to permit an "acceptable determination of the LD50".

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxypropylsilane

EC Number:

213-926-7

EC Name:

Trimethoxypropylsilane

Cas Number:

1067-25-0

Molecular formula:

C6H16O3Si

IUPAC Name:

trimethoxy(propyl)silane

Test animals

Species:

rat

Strain:

other: Wistar Bor:WISW (SPFTNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co., Borchen, GERMANY
- Age at study initiation: 57 days (males), 71-72 days (females)
- Weight at study initiation: 172-197 g (males), 146-164 g (females)
- Fasting period before study: 16 h
- Housing: Macrolon cages type II
- Diet: standard diet (Ssniff R, special diet for rats), ad libitum
- Water: drinking 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

IN-LIFE DATES: From: 25 February 1988 To: 12 March 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.62 ml/kg bw

Doses:

5170 mg/kg bw (males)
2401 or 5170 mg/kg bw (females)

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: observation for mortality twice daily (once daily on weekends and holidays); clinical observations after treatment continuously for 4-6 h then daily; bodyweights on days 0, 7, 14.
- Necropsy of survivors performed: yes, macroscopic examination included external appearance, body orifices, body cavities (thoracic and abdominal), and their contents.

Statistics:

None given. LD50 value for males is derived from a limit test (1 dose). The LD50 value for females (based on 2 doses) is described as an estimate.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 170 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 5 170 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Estimate

Mortality:

Two females died at 5170 mg/kg bw (3 - 4 hours after exposure). There were no deaths in males at this dose or in females at 2401 mg/kg bw.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

See Table 2 (Any other information on results including tables).

Gross pathology:

The stomach and intestines of the two females that died were filled with liquid and the mucosa of the proventricular was red.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity, and time range within which mortality occurred

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined			Male	Female	Combined
2401	-	0/5	0/5	n/a	Reduced locomotion Impaired co-ordination Loss of muscle tone Loss of righting reflex - lateral Loss of righting reflex - supine Loss of pinna, pain, corneal reflexes Clonic spasms Excitation-like twitching Ptosis (drooping eyelid) Lacrymation Mydriasis (dilated pupils) Hypersialosis (excessive salivation) Fur, ruffled Laboured breathing Reduced body temperature Abnormal gait Sunken flanks Cyanosis	- - - - - - - - - - - - - - - - - -	4/5 4/5 2/5 1/5 1/5 0/5 1/5 0/5 0/5 1/5 0/5 0/5 1/5 0/5 1/5 1/5 2/5 0/5	- - - - - - - - - - - - - - - - - -
5170	0/5	2/5	2/10	3-4 h	Reduced locomotion Impaired co-ordination Loss of muscle tone Loss of righting reflex - lateral Loss of righting reflex - supine Loss of pinna reflex Loss of pain reflex Loss of corneal reflex Clonic spasms Excitation-like twitching Ptosis (drooping eyelid) Lacrymation Mydriasis (dilated pupils) Hypersialosis (excessive salivation) Fur, ruffled Laboured breathing Reduced body temperature Abnormal gait Sunken flanks Cyanosis	5/5 5/5 4/5 2/5 2/5 0/5 0/5 0/5 1/5 0/5 0/5 0/5 0/5 0/5 0/5 4/5 0/5 0/5 1/5 0/5	4/5 4/5 3/5 3/5 3/5 2/5 2/5 2/5 0/5 1/5 2/5 0/5 2/5 4/5 1/5 4/5 2/5 1/5 3/5 2/5	9/10 9/10 7/10 5/10 5/10 2/10 2/10 2/10 1/10 1/10 2/10 0/10 2/10 4/10 1/10 8/10 2/10 1/10 4/10 2/10

 

 

Table 2: Body weights (g) – individual values

Dose (mg/bw day)	Animal No.	0 d	7 d	14 d
Males
5170	1 2 3 4 5	188 172 194 197 186	226 203 236 231 217	258 235 271 265 249
Females
2401	11 12 13 14 15	156 164 150 164 148	171 183 166 186 165	185 190 176 191 171
5170	6 7 8 9 10	150 162 154 146 149	168 182 - - 170	171 186 - - 178

 

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

In an acute oral toxicity study conducted in compliance with the now deleted OECD 401, but not to GLP (reliability score 2), the LD50 values for trimethoxy(propyl)silane were > 5170 mg/kg bw in males and 5170 mg/kg bw (estimated) in females. These values indicate low acute toxicity by the oral route. The most common signs of toxicity were reduced locomotion, impaired co-ordination, loss of muscle tone and loss of righting reflex.