Registration Dossier
Registration Dossier
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EC number: 200-929-3 | CAS number: 76-05-1
Repeated dose toxicity: inhalation
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 964
- 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 substance name:
- Trifluoroacetic acid
- EC Number:
- 200-929-3
- EC Name:
- Trifluoroacetic acid
- Cas Number:
- 76-05-1
- Molecular formula:
- C2HF3O2
- IUPAC Name:
- trifluoroacetic acid
- Details on test material:
- Data from handbook, no specific composition is available.
Constituent 1
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.
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