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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:
04.03.2002 to 13.08.2002
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD/Crl:CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: Males: 41 days; Females: 48 days
- Weight at study initiation: Males: 206-224 g; Females: 172-197 g
- Fasting period before study: 16 hours before treatment
- Housing: Type III Makrolon cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 55± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.04.2002 To: 02.05.2002

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: Not stated, but assumed to be low toxicity
- Lot/batch no. (if required): No data
- Purity: No data


MAXIMUM DOSE VOLUME APPLIED: 1.96 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose
Doses:
200 and 2000 mg/kg bw
No. of animals per sex per dose:
Three
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6 and 24 hours after administration. Weight: before and then weekly after administration
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw resulted in one male and two female deaths. No deaths at 200 mg/kg bw
Clinical signs:
All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.
There were no signs of toxicity at 200 mg/kg bw.
Body weight:
There were no effects on body weight gain.
Gross pathology:
No abnormalities were found.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute toxic class study conducted to OECD 423 and to GLP (reliability score 1) the acute oral LD50 for 3-chloropropyl(dimethoxy)methylsilane was in the range 200-2000 mg/kg bw in rats. All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.