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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:
1995/01/12 - 1995/02/03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1-6376 Alkoxysilane

- Substance type: Alkoxy-Si

- Physical state: Clear liquid

- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Laboratories, Inc., Raleigh, NC

- Age at study initiation: ca. 9 weeks

- Weight at study initiation: 158-175g males, 119-126g females

- Fasting period before study: 19 hours before dosing

- Housing: Individual hanging stainless steel wire mesh cages in an animal room.

- Diet: Certified Rodent Chow #5002, (Purina Mills, Inc, St.Louis, Missouri) ad libitum

- Water: ad libitum

- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 66-67 (18.9-19.4 °C)

- Humidity (%): 44-50

- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 10/01/1995 To: 03/02/1995

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.02 ml/kg


Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed approximately 1,2 and 4 hours after test article administration on study day 1, then twice daily (morning and afternoon) for 13 additional days (once on the day of necropsy). Individual body weights were obtained immediately prior to test article administration, on study day 8 and at study termination (day 15).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by carbon dioxide inhalation overdose) at study termination (day 15); no tissues were saved.
Statistics:
No statistical analysis is included in the report.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the 14 day study period.
Clinical signs:
The clinical signs noted during the study period were soft stool and anogenital staining. Soft stool was noted in all animals on study day 1 while anogenital staining was noted in six animals only on study day 1 while anogenital staining was noted in six animals only on study day 2 and in one animal on study days 2 and 3. These signs may be test article-related.
Body weight:
No apparent effects were observed in body weight gains.
Gross pathology:
No macroscopic findings were noted at the time of necropsy.
Other findings:
No other findings reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 value of >2000 mg/kg bw was determined for rats in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.