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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 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)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloro(chloromethyl)dimethylsilane
EC Number:
217-006-6
EC Name:
Chloro(chloromethyl)dimethylsilane
Cas Number:
1719-57-9
Molecular formula:
C3H8Cl2Si
IUPAC Name:
chloro(chloromethyl)dimethylsilane
Test material form:
other: colourless liquid
Details on test material:
Purity 99.4% (GC)

Test animals

Species:
rat
Strain:
other: Cri: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
6 male and three female animals
Body weight (at start of administration): male 192 - 251 g, female 185 - 193 g
Age (at start of adaptation): male 41 days, female 53 days
Identification of animals: by coloured marks and cage labels
Duration of experiment: at least 5 adaptation days, 1 test day, 2 recovery weeks

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: The test substance was used as supplied for the highest dose level of 2000 mg/kg body weight. Corn oil was used as vehicle for the second dose level of 200 mg/kg body weight.
Details on oral exposure:
The test substance was used as supplied for the highest dose level of 2000 mg/kg
body weight. Corn oil was used as vehicle for the second dose level of 200 mg/kg
body weight.
Administration volume: 1.84 mL/kg b.w.
Doses:
2000 mg/kg b.w.
200 mg/kg b.w.
No. of animals per sex per dose:
Order of administration
1) 2000 mg/kg b.w., male animals
2) 200 mg/kg b.w., male animals
3) 200 mg/kg b.w.,female animals
Control animals:
yes
Details on study design:
Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
Statistics:
No statistical analysis was performed (The method used was not intended to allow the
calculation of a precise LD50 value).

Results and discussion

Preliminary study:
2000 mg/kg b.w. resulted in the death within 3 hours of all male animals.
2000 mg/kg resulted following signs of systemic toxicity:
reduced motility, ataxia, reduced muscle tone, dyspnoea.
None of the six CD rats employed at 200 mg/kg b.w. died.
200 mg/kg in male animals resulted following signs of systemic toxicity:
reduced motility, ataxia, reduced muscle tone.
The three female animals at 200 mg/kg b.w. showed no signs of systemic toxicity.
2 of 3 surviving male animals gained the expected body weight within the study
period, one of 3 male animals showed a body weight reduction of 33.5%. All female
surviving animals gained the expected body weight within the study period.
Intestine inflated of all males at 2000 mg/kg body weight and in addition filled with
dark content of one male were found at macroscopic post mortem examination.
Caecum inflated of all males and females at 200 mg/kg body weight and in addition
intestine inflated of one male were also noted.
The oral LD50 value for Chlormethyl-dimethyl-chlorsilan in CD rats was ranked within
the LD50 range of 200 - 2000 mg/kg body weight.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No-effect dose level: <200 mg/kg b. w., by oral administration
Dose level with first intolerance reactions: 200 mg/kg b.w., by oral administration
Lowest lethal dose level: 2000 mg/kg b.w., by oral administration
LD50: 200 - 2000 mg/kg b.w., by oral administration
Clinical signs:
2000 mg/kg resulted following signs of systemic toxicity:
reduced motility, ataxia, reduced muscle tone, dyspnoea.
200 mg/kg in male animals resulted following signs of systemic toxicity:
reduced motility, ataxia, reduced muscle tone.
Body weight:
2 of 3 surviving male animals gained the expected body weight within the study
period, one of 3 male animals showed a body weight reduction of 33.5%. All female
surviving animals gained the expected body weight within the study period.
Gross pathology:
Intestine inflated of all males at 2000 mg/kg body weight and in addition filled with
dark content of one male were found at macroscopic post mortem examination.
Caecum inflated of all males and females at 200 mg/kg body weight and in addition
intestine inflated of one male were also noted.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the EC-Commission directive 67/548/EEC and its subsequent
amendments on the approximation of the laws, regulations and administrative
provision relating to the classification, packaging and labelling of dangerous
substances and the results obtained under the present test conditions
Chlormethyl-dimethyl-chlorsilan has to be classified as harmful
(200 mg/kg < LD50 < 2000 mg/kg).
Executive summary:

2000 mg/kg b. w. resulted in the death within 3 hours of all male animals.

2000 mg/kg resulted following signs of systemic toxicity:

reduced motility, ataxia, reduced muscle tone, dyspnoea.

None of the six CO® rats employed at 200 mg/kg b.w. died.

200 mg/kg in male animals resulted following signs of systemic toxicity:

reduced motility, ataxia, reduced muscle tone.

The three female animals at 200 mg/kg b.w. showed no signs of systemic toxicity.

2 of 3 surviving male animals gained the expected body weight within the study

period, one of 3 male animals showed a body weight reduction of 33.5%. All female

surviving animals gained the expected body weight within the study period.

Intestine inflated of all males at 2000 mg/kg body weight and in addition filled with

dark content of one male were found at macroscopic post mortem examination.

Caecum inflated of all males and females at 200 mg/kg body weight and in addition

intestine inflated of one male were also noted.

The oral LD50 value for Chlormethyl-dimethyl-chlorsilan in CO® rats was ranked within

the LD50 range of 200 - 2000 mg/kg body weight.

According to the EC-Commission directive 67/548/EEC and its subsequent

amendments on the approximation of the laws, regulations and administrative

provision relating to the classification, packaging and labelling of dangerous

substances and the results obtained under the present test conditions

Chlormethyl-dimethyl-chlorsilan has to be classified as harmful

(200 mg/kg < LD50 < 2000 mg/kg).

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