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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:
04.06.03 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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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.