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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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:
2002-03-13 to 2002-07-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
There were minor deviations from the guideline with respect to selection of doses.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

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 used, the guideline (2001) recommends 2000 followed by 300 mg/kg bw.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichlorocyclohexylmethylsilane
EC Number:
226-956-0
EC Name:
Dichlorocyclohexylmethylsilane
Cas Number:
5578-42-7
Molecular formula:
C7H14Cl2Si
IUPAC Name:
dichloro(cyclohexyl)methylsilane

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). 53 d (f)
- Weight at study initiation: 160-169 g (m), 168-176 (f)
- Fasting period before study: not stated
- Housing: 2-3/Makrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES:unclear

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: presumably 200 mg/ml
- Justification for choice of vehicle: 'to buffer off the irritating effect'
- Lot/batch no. (if required): 81K2204

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg bw
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: observations at 5, 15, 30 and 60 minutes, 3, 6 and 24 h, then at least daily until day 14; body weights weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology on organs showing lesions
Statistics:
None

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:
none
Clinical signs:
other: none
Gross pathology:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, identified an acute oral LD50 value greater than 2000 mg/kg bw in male and female rats. There was no evidence of toxicity at the tested dose.