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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
Study period:
7 DAY
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: LACK OF CERTIFICATE

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute toxicity determined by single oral adminstration to rat.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):liquid boron 135 g/l
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:135g/l in water
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:
rat
Strain:
other: rat Hsd. Brl:WH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan UK Ltd., Bicester
- Age at study initiation:4-6 weeks old
- Weight at study initiation:124-147 g
- Fasting period before study:overnight prior to test
- Housing:stainless steel mesh cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:10%
- Amount of vehicle (if gavage):20ml/Kg
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:135 g/l/2000 mg/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
20 mL/kg
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?)8 days
- Frequency of observations and weighing:day 1 and 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:weight gains between days 1 and 8

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: acute median and minimum lethal dose
Effect level:
> 2 000 mg/kg bw
Based on:
dissolved
Mortality:
none
Clinical signs:
none
Body weight:
Increased in each case
Gross pathology:
no effects
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Single oral administration of liquid boron 135 g/L to a group of four fasted rats at a dose level of 2000 mg/kg had no adverse effects. Accordingly, the acute median lethal oral dose and the minmum lethal oral dose to rats was shown to exceed 2000mg/kg bodyweight.
Executive summary:

Two male and female fasted rats were dosed with liquid boron 135g/L at 2000 mg/Kg on day 1. The test article was dispered in purified water at a concentration of 10% m/v and administered by oral lavage at a dose volume of 20 mL/Kg. All animals were killed on Day 8 and subsequently underwent a terminal macrosopic examination.

No animal died. There were no clinical signs of of systemic toxicity. All rats made substantial body weight gains between day 1 and day 8. No macroscopic changes were apparent at necroscopy on day 8.

Single oral administration of liquid boron 135 g/L to a group of four fasted rats at a dose level of 2000 mg/kg had no adverse effects. Accordingly, the acute median lethal oral dose and the minmum lethal oral dose to rats was shown to exceed 2000mg/kg bodyweight.