Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 May - 12 Sep 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:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns SozialesFreie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethoxymethyloctadecylsilane
EC Number:
274-936-5
EC Name:
Dimethoxymethyloctadecylsilane
Cas Number:
70851-50-2
Molecular formula:
C21H46O2Si
IUPAC Name:
(dimethoxymethyl)(octadecyl)silane
Details on test material:
- Name of test material (as cited in study report): Silan ODM-Dimethoxy
- Physical state: colourless liquid
- Storage condition of test material: at room temperature, dry, tightly closed, dark

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, Sulzfeld, Germany
- Age at study initiation: 42 (males) or 53 (females) days
- Weight at study initiation: 215 - 230 g (males); 206 - 231 g (females)
- Fasting period before study: yes (16 h before administration)
- Housing: 2-3 animals per cage during the 14-day observation period (MAKROLON cages, type III).
- Diet: ssniff/R/M-H V 1530 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: 13 May 2002 To : 02 Jul 2002

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.35 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
First step: 3 males
Second step: 3 females
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 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days (once daily). Body weight was determined before administration and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were observed at least once daily until all symptoms subsided (afterwards each working day).
Statistics:
No statistical analysis was performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
All surviving animals gained the expected body weight.
Gross pathology:
No abnormalities were observed.

Any other information on results incl. tables

Table 1: Body weights, body weight gain and autopsy findings of the surviving rats.

Body weights (body weight gain) [g]

Dose, oral gavage: 2000 mg/kg bw

 

male

female

start

225.0

216.3

after 7 days

283.0 (+25.7)

240.3 (+11.1)

after 14 days

308.3 (+37.0)

249.3 (+15.3)

Inhibition of body weight gain

none

none

Autopsy finding

none

none

Mortality

0/3

0/3

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an acute oral toxicity study conducted according to OECD 423 and in compliance with GLP, a LD50 >2000 mg/kg bw was observed in rats. No mortality and no clinical signs were observed. No effects on body weight gain and no abnormalities at necropsy were reported.