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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1970
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment, deficiencies in methodology

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Screening test for subacute inhalation toxicity
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tributylamine, not further specified

Test animals

Species:
rat
Strain:
other: Alderley Park
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
19 exposures in total
Frequency of treatment:
6 h/d, 5 d/wk
Doses / concentrations
Remarks:
Doses / Concentrations:
29, 62, 120 ppm (223, 477, 923 mg/m3)
Basis:
nominal conc.
No. of animals per sex per dose:
4
Control animals:
not specified
Positive control:
no

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
0.22 other: mg/l
Sex:
male/female
Basis for effect level:
other: slight lethargy

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

CLINICAL SIGNS
At 29 ppm: slight lethargy
at 62 ppm: more pronounced lethargy, no weight gain 
at 120 ppm: nose irritation, restlessness, incoordination and tremor, no weight gain

PATHOLOGY/HISTOLOGY
no substance-related organ effects were observed

Systemic effects were clear symptoms of neurotoxicity. The effect of the solvent (petrolether) is unclear

The influence of the petrolether  is unclear.


Applicant's summary and conclusion

Conclusions:
Due to deficiencies in data reporting and methodology (use of a solvent for the two lower exposure  levels with unknown influence on neurotoxic symptoms, low number of animals, no data on control animals, no analysis of  the exposure concentration), there can be drawn no conclusions from these results.
Executive summary:

Subacute inhalation exposure to 29, 62 and 120 ppm (223, 477 and 923 mg/m3, respectively, 19 exposures, 6 h/d, 5 d/w) produced slight lethargy in Alderley-Park rats at the lowest tested concentration of 29 ppm. The effects were more pronounced at 62 ppm and the animals showed no weight gain. Petrolether was used as solvent for these two lower exposures. At 120 ppm the animals showed nose irritation, restlessness, incoordination, tremors and no weight gain. The organs revealed no abnormalities (Gage, 1970).