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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-10 to 2002-07-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP. The read across is justified and the original reliability of the study is 1. The read across is considered reliability 2.

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)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorodimethylvinylsilane
EC Number:
217-007-1
EC Name:
Chlorodimethylvinylsilane
Cas Number:
1719-58-0
Molecular formula:
C4H9ClSi
IUPAC Name:
chloro(dimethyl)vinylsilane

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 d (m), 50 d (f)- Weight at study initiation: 203-283 g (m), 170-190 g (f)- Housing: 2-3/Makrolon Type III cage- Diet: standard diet ad libitum- Water: drinking water ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 3- Humidity (%): 55 +/- 15- Air changes (per hr): not stated - Photoperiod (hrs dark / hrs light): 12 h/12 hIN-LIFE DATES: From: unclear To: 2002-07-08

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
for the 200 mg/kg bw dose only
Details on oral exposure:
VEHICLEcorn oil- Lot/batch no. (if required): 81K2204MAXIMUM DOSE VOLUME APPLIED: 2.27 mg/kg bw
Doses:
2000 mg/kg bw (m)200 mg/kg bw (m/f)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: clinical observations at 5, 15, 30 and 60 minutes; 3, 6 and 24 h and then daily for 14 days. Body weights - weekly.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, histopathology of tissues with evident lesions
Statistics:
None

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths and no overt signs of systemic toxicity.
Sex:
male
Dose descriptor:
LD100
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: 3/3 (m)200 mg/kg bw 0/3 males; 0/3 females
Clinical signs:
2000 mg/kg bw (3m): reduced motility, ataxia in all animals, reduced muscle tone, dyspnoea and vocalisation in one.200 mg/kg bw (3m/3f): no overt signs of toxicity
Body weight:
2000 mg/kg bw: no data as all animals dead within 24h200 mg/kg bw: no treatment-related effect
Gross pathology:
Nothing remarkable reported

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 30 minutes

3/3:reduced motility, ataxia

1/3: reduced muscle tone, dyspnoea and vocalisation 

200

0/3

0/3

0/6

-

0/3 died and no clinical signs or effect on body weight

0/3 died and no clinical signs or effect on body weight

 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
A reliable study conducted largely in compliance with a standard guideline and GLP, identified an acute oral LD50 between 200 and 2000 mg/kg bw for male and females rats, treated via gavage.

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