Registration Dossier

Administrative data

Description of key information

Tributyl borate is rapidly hydrolyzed to Boric acid and n-Butanol in the presence of water or moisture in the air (18.3 sec at 21°C). Reliable endpoint data of the hydrolysis products n-Butanol and Boric acid are used, which is entirely appropriate to draw conclusions on the acute toxicity of Tributyl borate by the oral route:

1) Hydrolysis product n-Butanol

LD50 in female rats: 2290 mg/kg bw.

2) Hydrolysis product Boric acid

- LD50 in male rats: 3450 mg/kg bw (2950 - 4040 mg/kg bw);

- LD50 in female rats 4080 mg/kg bw (3640 - 4560 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on hydrolysis product Boric acid
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
other: No data
Deviations:
not specified
Principles of method if other than guideline:
Boric acid was administered orally by gavage to six groups of five male and five female albino Sprague-Dawley rats. The test material was administered as a 50 % w/v suspension in 0.5 % aqueous methyl cellulose at dosage levels of 2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw. Rats were fasted for a period of 3 to 4 h prior to dosage. Animals were observed for mortality and toxic effects at 1, 2, 4, and 24 h and once daily after for a total of 14 days. At the end of the observation period the surviving animals were weighed sacrificed and autopsies were performed.
GLP compliance:
no
Remarks:
Study pre-dates GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Males: 267 - 302 g; Females: 214 - 248 g
Route of administration:
oral: gavage
Vehicle:
other: 0.5 % aqueous methyl cellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % w/v

MAXIMUM DOSE VOLUME APPLIED: 3450 - 4080 mg/kg bw
Doses:
2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw.
No. of animals per sex per dose:
Five animals/group; no further data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Statistics:
Litchfield and Wilcoxon
Sex:
male
Dose descriptor:
LD50
Effect level:
3 450 mg/kg bw
Based on:
test mat.
95% CL:
2 950 - 4 040
Remarks on result:
other: mg boric acid/kg
Sex:
female
Dose descriptor:
LD50
Effect level:
4 080 mg/kg bw
Based on:
test mat.
95% CL:
3 640 - 4 560
Remarks on result:
other: mg boric acid/kg bw
Mortality:
No data
Clinical signs:
Symptoms include sings of CNS depression, ataxia, convulsions, laboured breathing or rapid respiration; blood crust around nose, marked diarrhoea and ptosis.
Body weight:
No data
Gross pathology:
Autopsies indicated congestion of lungs, kidneys and adrenals; inflammation of the pyloric portion of stomach and small intestine.
Other findings:
No data
Interpretation of results:
other: EU-GHS criteria not met
Conclusions:
The acute oral LD50 of boric acid for male albino rats was 3450 (2950 - 4040) mg boric acid/kg, equivalent to 604 mg B/kg bw. In female albino rats the acute oral LD50 of boric acid was 4080 (3640 - 4560) mg boric acid/kg, equivalent to 714 mg B/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on hydrolysis product n-Butanol
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Test material was administered by oral gavage to rats at various dose levels. Survivors were observed for 14 days after dosing.
GLP compliance:
no
Remarks:
performed prior to GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Harlan Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Dosage levels differ by a factor of 2 in a geometric series.
No. of animals per sex per dose:
Number of female rats used not stated in report but typically 6 rats are used/dose level.
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
2.83 mL/kg bw
Based on:
test mat.
Remarks on result:
other: original value
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 292 mg/kg bw
Based on:
test mat.
Remarks on result:
other: converted value (calculated with a density 0.81 g/mL)

No additional information available.

Interpretation of results:
other: EU-GHS criteria not met
Conclusions:
LD50 in female rats: 2.83 ml/kg, corresponding to 2290 mg/kg bw
Executive summary:

The acute oral toxicity of n-butanol was determined in a study comparable to OECD TG 401.

60-day-old female Harlan Wistar rats were dosed with the test material at various dose levels per gavage. The acute LD50 value was 2.83 mL/kg bw in female rats, corresponding to 2290 mg/kg bw (calculated with a density of 0.81 g/mL). No further data were available.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification


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