3-(triethoxysilyl)propanethiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 March 2019 to 18 April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(triethoxysilyl)propanethiol

EC Number:

238-883-1

EC Name:

3-(triethoxysilyl)propanethiol

Cas Number:

14814-09-6

Molecular formula:

C9H22O3SSi

IUPAC Name:

3-(triethoxysilyl)propanethiol

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For all animals of the first step, 2.0068 g of the test item was diluted with the vehicle to yield a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. For all animals of the second step, 2.0002 g of the test item was diluted with the vehicle to yield a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 10 weeks
- Weight at study initiation: Step 1: 153 – 177 g; Step 2: 189 – 200 g
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: This vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): MKCG3257
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): For all animals of the first step, 2.0068 g of the test item was diluted with the vehicle to yield a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. For all animals of the second step, 2.0002 g of the test item was diluted with the vehicle to yield a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Doses:

2000 mg/kg bw/day in step 1 and 2

No. of animals per sex per dose:

3 animals per step 1 and 2. Overall 6 animals used.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Not used

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration in step 1 and 2.

Clinical signs:

No specific sings of systemic toxicity were seen in any of the test animals.

Body weight:

None of the animals showed weight loss during the observation period.

Gross pathology:

No specific findings were seen during pathology examination.

Other findings:

No

Any other information on results incl. tables

Table 1: Absolute Body Weights in g and Body Weight Change in %

Step	Animal No. / Sex	Starting Dose  (mg/kg bw)		BW (g)		Body Weight Change in Comparison to Day 1 (%)
			Day 1	Day 8	Day 15	Day 15
1	1 / Female	2000	177	208	215	21
	2 / Female		158	193	202	28
	3 / Female		153	173	184	20
2	4 / Female	2000	189	217	224	19
	5 / Female		193	195	214	11
	6 / Female		200	221	225	13

Table 2 - Table 2: Findings of the Necropsy - Individual data

Step	Animal No. / Sex	Starting Dose (mg/kg bw)	Organ	Macroscopic Findings
1	1 / Female	2000	-	nsf
	2 / Female		-	nsf
	3 / Female		-	nsf
2	4 / Female		-	nsf
	5 / Female		-	nsf
	6 / Female		-	nsf

nsf = no specific findings

Table 3: LD₅₀Cut-Off

Starting Dose (mg/kg bw)	Number of Animals	Number of Intercurrent Deaths	LD50Cut-Off (mg/kg bw)
2000	6	0	˃ 5000

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the concluded LD50 value was greater than 2000 mg/kg bw.