Trichloroisobutylsilane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 May to 14 July 1993 (not further specified)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted largely in accordance with the OECD guideline and with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

dose not suitable for limit test

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trichloroisobutylsilane

EC Number:

242-053-4

EC Name:

Trichloroisobutylsilane

Cas Number:

18169-57-8

Molecular formula:

C4H9Cl3Si

IUPAC Name:

trichloro(2-methylpropyl)silane

Test animals

Species:

rat

Strain:

other: Hsd/Win:WU (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, GERMANY
- Age at study initiation: -
- Weight at study initiation: 138-180 g (males), 125-159 g (females)
- Fasting period before study: -
- Housing: max 5/Makrolon cage type III
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: unclear - study conducted between1993-05-17 and 1993-07-14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 1.72 ml/kg bw

Doses:

pretest 2000 mg/kg bw
main test 200 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw : 2
200 mg/kg bw: 10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and weekly, respectively
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

200 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Mortality:

Main test 200 mg/kg bw: deaths of 5/10 males from 3-6 days after treatment and 4/10 females from 3-9 days.
Pretest 2000 mg/kg bw: death of 2/2 males and 2/2 females within 45 minutes.
See also table 1.

Clinical signs:

other: All animals showed signs of toxicity during the 14 day observation, 3 males and 5 females were symptom-free at 14 days. Observations included sedation, ataxia, reduced motility, tremor, and bloody saliva or nasal secretions.

Gross pathology:

Those that died had clear evidence of the effects of acid burns to the gastro-intestinal tract and organs in close contact. Most that survived had adhesions of the thoracic or abdominal cavities, or changes to the gastric mucosa.

Other findings:

The test substance was noted to decompose in the presence of water, a concentration of 0.01% giving a pH of 2.52. The observed effects would be clearly associated with this property.

Any other information on results incl. tables

Table 1: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose (mg/kg bw)	Mortality (dead/total)			Time range of deaths (hours)	Number with evident toxicity
	Male	Female	Combined		Male	Female
Pretest 2000	2/2	2/2	4/4	Within 45 mins	-	-
Main test 200	5/10	4/10	9/20	3-9 days	10/10 affected during study, 3/10 symptom free after 14 days.	10/10 affected during study, 5/10 symptom free after 14 days.

 

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A study conducted in compliance with the standard guideline and with GLP status, but limited in some respects, identified LD50 values of 200 and >200 mg/kg bw, for male and female rats, respectively.

Executive summary:

A study conducted in the main in compliance with the standard guideline and with GLP status, but limited in some respects, identified LD₅₀ values in of 200 and >200 mg/kg bw, for male and female rats, respectively.