Tributylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1974

Report date:

1974

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Principles of method if other than guideline:

Method: acute oral toxicity test
Screening acc. to Smyth et al., 1962 (animals non-fasted, no necropsy is reported)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tributylamine

EC Number:

203-058-7

EC Name:

Tributylamine

Cas Number:

102-82-9

Molecular formula:

C12H27N

IUPAC Name:

tributylamine

Details on test material:

- Name of test material (as cited in study report): tributylamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in-house breeding
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Diet: Rockland rat diet

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Test substance probably applied in dilution, no data

Doses:

4 doses in a logarithmic series (factor 2) (acc. to Smyth et al. 1962)

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

420 mg/kg bw

Any other information on results incl. tables

LD50 value is given as 0.54 ml/kg bw (conversion to mg/kg bw was done using the density d= 0.78 g/ccm). Fiducial range values (+/- 1.96 S.D.) were from about 280 - 610 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Single application of a range of doses of the test item to male Wistar rats resulted in a LD50 = 420 mg/kg bw.

Executive summary:

Male Wistar rats (5 rats/sex/dose) were subjected to test acute oral toxicity. The test item (purity not mentioned) was administered by gavage to non-fasted animals in 4 different dose levels (logarithmic series) and were observed for further 14 days. The results obtained led to a LD50 = 420 mg/kg bw (Carpenter et al., 1974).

This published acute oral toxcicity study is, together with methodological details given in other publications of the group, performed well and basic data are given, thus the study can be juged reliable with restrictions (RL 2).