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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats and guinea pigs were exposed to vapors and aerosols of trifloroacetic acid for 4 hrs/day during 5 or 4 months.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Data from handbook, no specific composition is available.

Test animals

Species:
other: rats or guinea pigs
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: inhalation of vapors and aerosols
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: no data
Details on inhalation exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
4 hrs/day for 5 months (rats) or 4 months (guinea pigs)
Frequency of treatment:
6 times a week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0.4-0.7 mg/L Rats
Basis:
no data
Remarks:
Doses / Concentrations:
0.025-0.05 mg/L Guinea-pigs
Basis:
no data
No. of animals per sex per dose:
48 rats (12 served as control) or 30 guinea pigs (10 served as control).
Control animals:
yes
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
rats: body weight, body temperature, neuromuscular excitability, composition of the peripheral blood, liver and kidney functions and tissue respiration, sugar and residual nitrogen levels in the blood, oxygen consumption.
Guinea pigs: weight and composition of the peripheral blood

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
effects observed, treatment-related
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
not specified
Urinalysis findings:
effects observed, treatment-related
Behaviour (functional findings):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
CLINICAL SIGNS AND MORTALITY: no death occured within the course of the experiment. The irritant action caused by exposure to the products was reflected in the anxiety of the animals, breathholding, lachrymation, hyperaemia of the conjunctiva, and sanious and sanious-suppurative nasal discharge.

BODY WEIGHT AND WEIGHT GAIN: delayed weight gain

FOOD CONSUMPTION: no data

FOOD EFFICIENCY: no data

WATER CONSUMPTION: no data

OPHTHALMOSCOPIC EXAMINATION: hyperaemia of the conjunctiva and lachrymation

HAEMATOLOGY: an increase in the total leukocyte count and blood sugar level

CLINICAL CHEMISTRY

URINALYSIS: increased levels of protein in the urines

NEUROBEHAVIOUR: a reduction in the neuromuscular excitability in the second month of exposure. By the end of the period of the administration, the neuromuscular excitability of the animals had increased.

ORGAN WEIGHTS

GROSS PATHOLOGY: signs of irritation in the upper respiratory pathways (rhinitis, tracheitis, bronchitis) and lungs (thickening of the alveolar septa, peribronchitis, emphysema, pulmonary collapse). Distrophy of the liver and kidneys.

HISTOPATHOLOGY: NON-NEOPLASTIC

HISTOPATHOLOGY: NEOPLASTIC (if applicable)

HISTORICAL CONTROL DATA (if applicable)

OTHER FINDINGS: increase in body temperature of 1.5 to 2°C.

Effect levels

open allclose all
Dose descriptor:
LOAEL
Remarks:
Rat
Effect level:
< 0.05 mg/L air
Sex:
not specified
Basis for effect level:
other: severe signs of irritation of the respiratory pathway and of the eyes, effects in the liver and kidney and body weight loss
Dose descriptor:
LOAEL
Remarks:
Guinea-pigs
Effect level:
< 0.7 mg/L air
Sex:
not specified
Basis for effect level:
other: severe signs of irritation of the respiratory pathway and of the eyes, effects in the liver and kidney and body weight loss

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
The animals exposed to the test item showed severe signs of irritation of the respiratory pathway and of the eyes. There was also effects in the liver and kidney and the animals displayed a body weight loss.
Executive summary:

In a subchronic inhalation study, rats and guinea pigs were exposed to a mixture of vapors and aerosols of trifluoroacetic acid (concentrations comprised between 0.025 and 0.05 mg/L or 0.4 and 0.7 mg/L). The animals were exposed for 4 hrs per day (six days per week) for a period of 5 (rats) or 4 (guinea pigs) months.

There is no detailed information on the study design.

Exposed animals showed severe signs of irritation of the respiratory pathway and of the eyes. There was also effects in the liver and kidney and the animals displayed a body weight loss.

In these study there is no NOAEL.