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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:
2004-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 425, OPPTS 870.1100 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Trimethyl borate
- Physical state: clear liquid with an alcohol odor
- Composition of test material, percentage of components: > 99%
- Lot/batch No.: Lot #42Y4A09T, TD#04-001 further identified with PSL Reference Number 040210-3R
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: stored in a tightly closed container, at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Received i?om Ace Animals, Inc., Boyertown, PA
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 221-247 grams at experimental start
- Fasting period before study: yes
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conformed to the size recommendations in the Guide for the Care and Use ofLaboratoiy Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012 was supplied ad-libitum (except during pre-dose fasting)
- Water (e.g. ad libitum): Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 20-28 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 °C
- Humidity (%): 33-68%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses were calculated based on the initial body weights, taking into account the specific gravity (determined by PSL) of the test substance - Specific Gravity - 0.930 g/ml
Doses:
2000 mg/kg
No. of animals per sex per dose:
An initial limit dose of 2,000 mg/kg of body weight was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females were sequentially dosed at the same dose level. Since all animals survived, no additional animals were tested.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
- Frequency of observations and weighing: Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 or (termination) after dosing
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was noted during the study period.
Clinical signs:
Following administration, clinical signs noted for all animals included piloerection, facial staining, hypoactivity, andlor reduced fecal volume. However, all animals recovered by Day 2, and appeared active and healthy for the remainder of the 14-day observation period.
Body weight:
All animals gained weight during the study period.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute oral LD50 of Trirnethyl Borate is greater than 2000 mg/kg of body weight in female rats and as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, Trimethyl Borate will not be classified.
Executive summary:

An acute oral toxicity test (Up and Down Procedure) was conducted with rats to determine the potential for Trimethyl Borate (Lot# Lot #42Y4A09T, TD#04-001, >99% Trimethyl Borate) to produce toxicity from a single undiluted dose via the oral route. An initial limit dose of 2,000 mg/kg of body weight was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females were sequentially dosed at the same dose level. Since all animals survived, no additional animals were tested.

All animals survived exposure to the test substance and gained body weight. Following administration, clinical signs noted for all animals included piloerection, facial staining, hypoactivity, and/or reduced fecal volume. However, all animals recovered by Day 2, and appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the acute oral LD50 of Trirnethyl Borate is greater than 2000 mg/kg of body weight in female rats and as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, Trimethyl Borate will not be classified.