Dichloromethyl(3,3,3-trifluoropropyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 May 2002 to 26 July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

FREIE UND HANSESTADT HAMBURG, BEHÖRDE FÜR ARBEIT, GESUNDHEIT UND SOZIALES, Hamburg, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dichloromethyl(3,3,3-trifluoropropyl)silane

EC Number:

211-623-4

EC Name:

Dichloromethyl(3,3,3-trifluoropropyl)silane

Cas Number:

675-62-7

Molecular formula:

C4H7Cl2F3Si

IUPAC Name:

(dichloromethyl)(3,3,3-trifluoropropyl)silane

Details on test material:

- Name of test material (as cited in study report): Silane 2813, Wacker-Chemie GmbH Test Substance No . 60018428, Receipt No. 24753
- Substance type: chlorosilane
- Physical state: colourless liquid
- Odour: none (according to LPT), pungent (according to sponsor)
- Batch No.: QB15034
- Expiration date of the lot/batch: 01-01-2004
- Stability under test conditions: stability in vechicle (corn oil) at +4°C in dark: > 1 day
- Storage condition of test material: at room temperature, dark, tightly closed, dry, no contact with oxygen
- Stability under storage conditions: at + 25 °C > 1 year
- Density: 1.27 g/cm³
- Date of Receipt: 2002-04-17

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl:CD
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 42 days (males), 50 days (females).
- Weight at study initiation: 170-194 g (males), 175-183 g (females)
- Fasting period before study: 16 hours
- Housing: Animals were kept in groups of 2-3 in Makrolon cages (types III). Granulated textured wood (Granulate A2, J. Brandenburg, D-49424 Goldenstedt) was used as bedding material for the cages.
- Diet: Ssniff R/M-H V 1530 (ssniff spezialdiaten GmbH, D-59494 Soest) served as food. Feed was discontinued approx. 16 hours before administration;only tap water was then available ad libitum.
- Water: Drinking water in bottles was offered ad libitum.
- Acclimation period: At least 5 adaptation days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

IN-LIFE DATES: From:13 May 2002 to: 26 June 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

Corn oil was used as vehicle for the 200 mg/kg dose only.The test substance was used as supplied for the 2000 mg/kg dose.

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.57 mL/kg bw

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

3 males - 2000 mg/kg bw.
3 males and 3 females -200 mg/kg bw.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, at 5, 15, 30 and 60, as well as at 3, 6 and 24 hours after administration. Observation on mortality was made at least once daily. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death.
- Necropsy of survivors performed: yes. At the end of the experiment (in the morning of test day 15), all surviving animals were sacrificed, dissected and inspected macroscopically. From animals which survived 24 hours or longer, a microscopic examination of all organs which showed evident lesions was performed. Autopsy and macroscopic inspections of animals which died prematurely were carried out as soon as possible after exitus.
- Other examinations performed: organ weights, histopathology, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed.

Statistics:

No statistical analysis was performed (The method used was not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 range given in the study report

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: The LD50 cut-off value was determined on the basis of the interpretation flowchart of the followed OECD guideline.

Mortality:

2000 mg/kg bw resulted in the death of two male CD rats within 4 days.
200 mg/kg bw resulted in the death of one male and one female CD rat within 4 days.

Clinical signs:

other: No signs of systemic toxicity were noted at both 2000 and 200 mg/kg bw (See tables 1 & 2 for detail).

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

Table 1. Results summary

Symptoms/ criteria	2000 mg/kg bw		200 mg/kg bw
	Male (n = 3)		Male (n = 3)	Female (n = 3)
Animal with no intolerance reactions	3	-	3	3
Mortality
Within 6 hours	0	-	0	0
Within 2 days	0	-	0	0
Within 7 days	2	-	1	1
Within 14 days	2	-	1	1
Mean weight in g
Start	190.3	-	175.7	180.0
After 7 days	247.0 (+ 29.3)	- -	230.5 (+ 31.5)	225.0 (+ 26.1)
After 14 days	264.0 (+ 38.2)	- -	295.0 (+ 69.3)	231.0 (+ 29.4)
Inhibition of body weight gain	None	-	None	None
Autopsy findings	None	-	None	None

- = not observed        In brackets = body weight gain in %

Table 2. Clinical signs / Individual data

Clinical Signs
Test day			1	1	1	1	1	1	1	2	3	4	5-14d
Time after Administration			0	5’	15’	30’	60’	3h	6h	24h
Animal no./sex		Clinical signs
2000 mg silan 2813 /kg bw
1 m	None		-	-	-	-	-	-	-	-	-	-	-
2 m	Death		-	-	-	-	-	-	-	-	*
3 m	Death		-	-	-	-	-	-	-	-	-	*

  - = not observed        * = animal died prematurely        m = Male

Table 3. Clinical signs / Individual data

Clinical Signs
Test day			1	1	1	1	1	1	1	2	3	4	5-14d
Time after Administration			0	5’	15’	30’	60’	3h	6h	24h
Animal no./sex		Clinical signs
200 mg silan 2813 /kg bw
4 m	None		-	-	-	-	-	-	-	-	-	-	-
5 m	death		-	-	-	-	-	-	-	-	*
6 m	None		-	-	-	-	-	-	-	-	-	-	-
7 f	None		-	-	-	-	-	-	-	-	-	-	-
8 f	Death		-	-	-	-	-	-	-	-	-	*
9 f	None		-	-	-	-	-	-	-	-	-	-	-

- = not observed        * = animal died prematurely       m = Male       f = Female

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study conducted according to the OECD TG 423, and in compliance with GLP, an LD50 range of 200-2000 mg/kg bw was identified. 2000 mg/kg bw resulted in the death of two male CD rats within 4 days. No signs of systemic toxicity were noted at 2000 mg/kg bw. 200 mg/kg bw resulted in the death of one male and one female CD rat within 4 days. No signs of systemic toxicity were noted at 200 mg/kg bw.