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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
from 7 May to 28 June 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted largely in accordance with the OECD guideline and with GLP.

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 not as recommended in OECD 423 (2001)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trichloro(2,4,4-trimethylpentyl)silane
EC Number:
242-262-0
EC Name:
Trichloro(2,4,4-trimethylpentyl)silane
Cas Number:
18379-25-4
Molecular formula:
C8H17Cl3Si
IUPAC Name:
trichloro(2,4,4-trimethylpentyl)silane

Test animals

Species:
rat
Strain:
Sprague-Dawley
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: 41 days (males), 48 days (females)
- Weight at study initiation: 179-215 g(males), 175-210 g (females)
- Fasting period before study: 16 h
- Housing: 2-3/Makrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 5 cycles (each of 1 day treatment and 14 days observation) overlapping in some cases From: 2002-05-07 To: 2002-06-28

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: neat at 2000 mg/kg bw; in corn oil at 200 and 25 mg/kg bw
Details on oral exposure:
VEHICLE
used for 200 and 25 mg/kg bw doses only
- Justification for choice of vehicle: not given
- Lot/batch no. (if required): 81K2204
- Purity: not stated

MAXIMUM DOSE VOLUME APPLIED: 1.87 ml/kg bw in all cases

DOSAGE PREPARATION (if unusual): not given

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not given
Starting dose 2000 mg/kg bw. The subsequent doses of 200 and 25 mg/kg bw are not as recommended in OECD 423 or the equivalent EC guideline L248: B.1 tris. Also, it is not clear why testing at the mid-dose was repeated in a second sex
Doses:
2000, 200 and 25 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw 3 males
200 mg/kg bw 3 males followed by 3 females
25 mg/kg bw 3 males followed by 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 6 observations on day 1, then daily observations and weekly weighings
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
None.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 25 - < 200 mg/kg bw
Mortality:
All males died at 2000 mg/kg bw and 2/3 died at 200 mg/kg bw. No females died at 200 mg/kg bw and no animals died at 25 mg/kg bw. (See also table 1.)
Clinical signs:
other: Slight to moderate reduced motiltiy, ataxia and dyspnoea, slightly reduced muscle tone or adopting a lateral or abdominal postition were noted in all animals of the 2000 mg/kg bw group. No clinical signs were noted in any other dose group. (See also table
Gross pathology:
No abnormalities were reported.
Other findings:
None

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

1h, 1h, 24h* 

3/3 reduced motility and ataxia; 2/3 reduced muscle tone, dyspnoea, prone position

200

2/3

0/3

2/6

1 day, 7 days 

3/3 no clinical signs 

3/3 no clinical signs  

25

0/3

0/3

0/6

 -

3/3 no clinical signs  

3/3 no clinical signs  

 * sacrificed as moribund

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A reliable study conducted very largely in compliance with the standard guideline and in accordance with GLP, identified an LD50 in the range 25-200 mg/kg bw in male and female rats. There was no evidence of toxicity at the lowest tested dose of 25 mg/kg bw.