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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
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.