Reaction products of monoethanolamine and boric acid (1:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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

Test material information

Constituent 1

Reference substance name:

MEA-Polyborate 1:3

IUPAC Name:

MEA-Polyborate 1:3

Details on test material:

- Name of test material (as cited in study report):
- 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:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:EU-SMG01696
- 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 or test system 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:

other: none

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 MEA Polyboate 1:3 135 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 MEA Polyboate 1:3 135g/L at 2000 mg/Kg on day 1. The test article was dispersed 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 macroscopic examination.

No animal died. There were no clinical signs 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 MEA Polyboate 1:3 135 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 minimum lethal oral dose to rats was shown to exceed 2000mg/kg bodyweight.