Trichloro(vinyl)silane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.06.03 to 18.06.03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

starting dose 200 mg/kg bw instead of 300 mg/kg bw.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(vinyl)silane

EC Number:

200-917-8

EC Name:

Trichloro(vinyl)silane

Cas Number:

75-94-5

Molecular formula:

C2H3Cl3Si

IUPAC Name:

trichloro(vinyl)silane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: 9 weeks
- Weight at study initiation: Body weight variation did not exceed ±20% of mean for the sex.
- Fasting period before study: overnight
- Housing: Macrolon Type IV cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: 04.06.03 to 18.06.03 (treatment dates)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: dehydrated olive oil with silica gel (3:1)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: Based on trial formulations
- Lot/batch no. (if required): No data
- Purity: No data


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

Doses:

200 and 2000 (females only) 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: Mortality: twice daily. Body weights: Day 1 (pre-administration), and Days 8 and 15. Clinical signs: periodically on the day of dosing and then daily.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination

Statistics:

No statistical analysis.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 2 000 mg/kg bw

Mortality:

No animals died when treated with 200 mg/kg bw. All females doses with 2000 mg/kg bw died within two hours of treatment.

Clinical signs:

At 200 mg/kg bw hunched posture, flat gait, piloerection, lethargy and alopecia (females) were observed. At 2000 mg/kg bw lethargy, hunched posture, uncoordinated movements, laboured breathing, rales, piloerection, bleeding from the snout, salivation, watery discharge from the eyes, pale appearance, ptosis and clonic spasms. The surviving animals had recovered from the symptoms between days 2 and 3, except for alopecia, which was observed throughout the observation period.

Body weight:

No effect on body weight.

Gross pathology:

At 2000 mg/kg bw dark red discolouration of the forestomach was observed. There were no findings in animals that survived to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a good quality acute oral toxicity study conducted to OECD test guideline 423 (acute toxic class) and GLP, the LD50 for trichloro(vinyl)silane was in the range of 200-2000 mg/kg bw in rats.

Executive summary:

In a good quality acute oral toxicity study conducted to OECD test guideline 423 (acute toxic class) and GLP, an initial dose of 200 mg/kg bw trichloro(vinyl)silane was administered to three female Wistar rats. In a stepwise procedure additional groups of animals were dosed with 200 mg/kg bw (males) and 2000 mg/kg bw (females). All animals were observed daily and body weights were measured weekly. At the end of a 14 day observation period all surviving animals were sacrificed. Macroscopic examinations were performed on all animals. No deaths occurred at 200 mg/kg bw, and all three females died within two hours after being given a dose of 2000 mg/kg bw. Therefore the oral LD₅₀ was in the range 200 -2000 mg/kg bw. At 200 mg/kg bw hunched posture, flat gait, piloerection, lethargy and alopecia (females) were observed. At 2000 mg/kg bw lethargy, hunched posture, uncoordinated movements, laboured breathing, rales, piloerection, bleeding from the snout, salivation, watery discharge from the eyes, pale appearance, ptosis and clonic spasms. The surviving animals ahd recovered from the symptoms between days 2 and 3, except for alopecia, which was observed throughout the observation period. At 2000 mg/kg bw dark red discolouration of the forestomach was observed. There were no effects on body weight.