Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

EC Number:

270-821-9

EC Name:

Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

Cas Number:

68478-46-6

Molecular formula:

C14H23BF3NO2

IUPAC Name:

1-phenylmethanamine; 7-[(benzylamino)methyl]-10-(butoxymethyl)-5,8,11,15-tetraoxaicosan-13-ol; benzyl(3-butoxy-2-hydroxypropyl)amine; benzyl[3-butoxy-2-(3-butoxy-2-hydroxypropoxy)propyl]amine; dibenzyl(3-butoxy-2-hydroxypropyl)amine

Test material form:

liquid: viscous

Details on test material:

Manufacturer Air Products and Chemicals, Inc.
Batch# / Lot # 1891585

Test animals

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.

Administration / exposure

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.

Results and discussion

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.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.64 mL/kg bw

Based on:

test mat.

95% CL:

> 0.47 - < 0.87

Effect levels 2

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.

Applicant's summary and conclusion

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.