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Toxicological information

Acute Toxicity: oral

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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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1974
Report Date:
1974
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

Reference
Name:
Unnamed
Type:
Constituent
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 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).