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Diss Factsheets

Administrative data

Description of key information

The acute median lethal oral dose (LD50) and its 95% confidence limits for Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether to rats were determined to be 750 (550 to 1018) mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Principles of method if other than guideline:
Material was administered undiluted by oral intubation in a range of dosage volumes in the full scale test of 0.25 to 1.6 ml/kg bodyweight to Rats of the CFY strain. Rats dosed with water (1.6 ml/kg) served as controls.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rats of the CFY strain, in the weight range 177 to 236 g starved overnight before dosing.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Anchor 1040 was administered undiluted by oral intubation in a range of dosage volumes in the full scale test of 0.25 to 1.6 ml/kg bodyweight. Rats dosed with water (1.6 ml/kg) served as controls.
Doses:
0.25 to 1.6 ml/kg
No. of animals per sex per dose:
2 in range finding test, 5 in final test
Control animals:
yes
Details on study design:
Anchor 1040 was administered undiluted by oral intubation in a range of dosage volumes in the full scale test of 0.25 to 1.6 ml/kg bodyweight. Rats dosed with water (1.6 ml/kg) served as
controls.
During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. Ail rats that died were examined macroscopically in an attemptto identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.
From the mortality data recorded, the LD50 and its 95% confidence limits were calculated by the method Weil C.S., (1952), Biometries -8, 249.
Preliminary study:
The results of preliminary range finding tests with 4 animals per dose indicated that the median lethal oral dose (LDS0), was in the region of 0.25 to 0.64 ml/kg bodyweight.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.64 mL/kg bw
Based on:
test mat.
95% CL:
> 0.47 - < 0.87
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
750 mg/kg bw
Based on:
test mat.
95% CL:
> 550 - 1 018
Mortality:
Death occurred from within three hours to four days of dosing. See attached table tor details.
Clinical signs:
other: Signs of reaction to treatment observed shortly after dosing, included lethargy, piloerection, abnormal body carriage (hunched posture) and increased salivation. These signs were accompanied by decreased respiratory rate in rats treated above 0.64 ml/kg,
Gross pathology:
Autopsy revealed haemorrhage of the lungs, pal lor of the I iver, kidneys and spleen and injectionof the intestinal blood vessels.
Other findings:

Recovery of surviving animals, as judged by external appearance and behaviour, was apparently complete within 7 day; of treatment.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute median lethal oral dose (LD50) and its 95% confidence limits for Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether to rats were determined to be 750 (550 to 1018) mg/kg bodyweight.
Executive summary:

The acute median lethal oral dose (LD50) and its 95% confidence limits for Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether to rats were determined to be 750 (550 to 1018) mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
750 mg/kg bw

Additional information

Justification for classification or non-classification