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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diacetoxydi-tert-butoxysilane
EC Number:
236-112-3
EC Name:
Diacetoxydi-tert-butoxysilane
Cas Number:
13170-23-5
Molecular formula:
C12H24O6Si
IUPAC Name:
diacetyl di-tert-butyl orthosilicate
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Stamm Wistar TNO W 74, Zuchter: Winkelmann, Borchen.
- Age at study initiation: 9 weeks.
- Weight at study initiation: 179g.
- Fasting period before study: No data
- Housing: Makrolon Type III cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: No vehicle. Administered undiluted.
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

DOSAGE PREPARATION (if unusual): No data
Doses:
3.1 or 5.0 ml/kg bw. (converts to 2616 and 4220 mg/kg bw using a density of 0.844 g/cm3).
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, followed by twice daily (once at weekends/public holidays).
- Necropsy of survivors performed: no
- Other examinations performed: body weights were recorded on the day of administration and on day 14 of the observation period.
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Deaths at the LD50 dose occurred in 2/10 animals within 2-4 days. No other deaths recorded. All animals given this dose showed signs of weight loss and sedation.
Mortality:
No deaths were observed following a dose of 3.1 ml/kg bw (2616 mg/kg bw).
In the high dose group (5 ml/kg bw equal to 4220 mg/kg bw) there was one death on day 2 and one death on day 4 following administration of the test substance.
Clinical signs:
No clinical signs were observed following a dose of 3.1 ml/kg bw (2616 mg/kg bw)
Sedation was observed in animals administered the highest dose of 5 ml/kg (4220 mg/kg bw).
Body weight:
Body weight was no reduced following a dose of 3.1 ml/kg bw (2616 mg/kg bw)
Body weight loss was observed in animals administered the highest dose of 5 ml/kg (4220 mg/kg bw).
Gross pathology:
No necropsy conducted.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on a summary of an acute oral gavage toxicity study (reliability score 2) the LD50 for diacetoxydi-tert-butoxysilane is 5ml/kg bw in Wistar rats. Using a density of (1.33g/cm3 the LD50 is converted to 6650 mg/kg bw.

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