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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with an appropriate OECD test method and in compliance with GLP using the hydrolysis product of the registered substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Laboratories, Inc., Raleigh, North Carolina

- Age at study initiation: 9 weeks

- Weight at study initiation: 175 g to 185 g.

- Fasting period before study: yes (18-20 hours before dosing)

- Housing:stainless steel, wire-mesh cages suspended above cage-board

- Diet: PMI Nutrition International, LLC, Certified Rodent LabDiet® 5002 ad libitum

- Water: Municipal water ad libitum

- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 ± 3 °C

- Humidity (%): 50 ± 20%

- Air changes (per hr): Not reported

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

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:

Mortality: 15 minutes and 1, 2 and 4 hours post-dosing on study day 0 and twice daily thereafter.

Clinical observations: 15 minutes and 1, 2 and 4 hours post-dosing on study day 0 and once daily thereafter

Body weights: Body weights were obtained and recorded on study days 0 (initiation), 7 and 14 (termination).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Not required

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on study day 2.
Clinical signs:
Clinical observations limited to the animal that died included partial closure of the right and left eyes, impaired equilibrium, hypoactivity, decreased respiration, soft feces, pale body, pale extremities and body cool to touch.

Clinical observations for all animals included wet yellow material on the urogenital, anogenital areas and/or ventral trunk. Single incidences of dried red material around the nose and hairloss and scabbing on the forelimbs were noted for individual surviving animals.
Body weight:
There were no remarkable body weight changes noted during the study.
Gross pathology:
There were no internal macroscopic findings at either the unscheduled or scheduled necropsies. Brown matting was noticed on the abdominal and urogenital areas for the animal that died during the study.
Other findings:
None 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 >2000 mg/kg for female albino rats was determined for dimethylsilanediol in a study according to OECD test guideline 425 (up & down method) and in compliance with GLP.