Trichloro(hexadecyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13-06-2002 to 12-08-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

doses of 2000 and 200 mg/kg bw were used, the guideline recommends 2000 followed by 300 mg/kg bw.

GLP compliance:

yes (incl. QA statement)

Remarks:

Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit und Soziales

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(hexadecyl)silane

EC Number:

227-575-2

EC Name:

Trichloro(hexadecyl)silane

Cas Number:

5894-60-0

Molecular formula:

C16H33Cl3Si

IUPAC Name:

trichloro(hexadecyl)silane

Test animals

Species:

rat

Strain:

other: Crl:CD®

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 41 days (males) and 48 days (females)
- Weight at study initiation: 196-215 g (males) and 174-185 g (females)
- Fasting period before study: 16 hours before dose administration.
- Housing:
- Diet :Ssniff®R/M-H V 1530 (ssniff Spezialfutter GmbH, 69494 Soest) served as food. Feeding was discontinued approximately 16 hours before administration.
- Water :Tap water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From:07-05-2002 To: 13-06-2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

Corn oil was only used as vehicle for the second dose level of 200 mg/kg bw.

Details on oral exposure:

VEHICLE
Corn oil
- Lot/batch no. 81K2204

MAXIMUM DOSE VOLUME APPLIED: 2.02 mL/ kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose used was selected from a series of defined dose levels. Three animals of one sex ('sex 1') are treated at 2000 mg/kg bw (step 1). When two or three animals die, testing at 200 mg/kg bw should be performed. When fewer than two animals die, the substance should be retested (second step) with 2000 mg/kg bw, using three animals of the other sex )'sex 2'). If, in this second step, two or three animals die, testing at 200 mg/kg bw should be performed. When, in this second step, fewer than two animals die, no further testing is necessary.

Doses:

2000 and 200 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: Animals were subjected to daily observations and weekly determinations of body weight.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

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.

Effect levels 2

Sex:

male

Dose descriptor:

LD100

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: all animals died with 24 hours of dosing.
200 mg/kg bw: no mortality occurred.

Clinical signs:

other: 2000 mg/kg bw: reduced motility, ataxia, reduced muscle tone, dyspnoea, abdominal position. 200 mg/kg bw: reduced motility, ataxia.

Gross pathology:

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

Any other information on results incl. tables

Table 1: Number of animals dead or with evident toxicity

Dose (mg/kg bw)	Mortality (dead/total)			Time range of deaths	Number with evident toxicity
	Male	Female	Combined		Male	Female
2000	3/3	-	3/3	Within 24 h	3/3: reduced motility, ataxia, reduced muscle tone, dyspnoea and abdominal position	-
200	0/3	0/3	0/6	-	3/3: reduced motility, ataxia; no effect on body weight	3/3: reduced motility, ataxia; no effect on body weight

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

A reliable study conducted largely in compliance with a standard guideline (acute toxic class method) and GLP, identified an oral LD50 between 200 and 2000 mg/kg bw for male and females rats, treated via gavage.