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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.