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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:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP; the results are only generally described, no quantitative information; data unclear

Data source

Reference
Reference Type:
publication
Title:
Begrundung der maximal zulassigen konzentration von paraChlorobenzotrifluorid in atomspharischer luft (German translation of the Russian).
Author:
Rapoport, K.A., Tepikina, L.A., Fel'dman, J.G., Mitrofanova, N.G., Carvey, O.G., Kosjanov, V.V., Capkova, N.N.
Year:
1986
Bibliographic source:
Gig. Sanit., 10, 82-83

Materials and methods

Principles of method if other than guideline:
The test method is an OECD 413-like, with several differences:
- exposure period: 4 months instead of 3
- exposure frequncy: 7 days per week instead of 5
- no analytical verification of the exposure concentrations
- 4 concentration levels + control instead of 3
- some deficiency in the analysed parameters (hystology, gross patology, clinical signs, clinical biochemistry)
- test animals: deficienciences in the test animals information (no data on strain and on number of exposed rats). Only male rats were used.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: no data
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
4 months
Frequency of treatment:
24 hours daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
5.5 mg/m3
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
20.5 mg/m3
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
71.6 mg/m3
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
440 mg/m3
Basis:
nominal conc.
No. of animals per sex per dose:
no data
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: not specified
BODY WEIGHT: Yes
- Time schedule for examinations: not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: not specified
- Parameters checked: erythrocyte count, erythrocyte volume, haemoglobin, methaemoglobin, haemoglobin/erythrocyte, hematocrit value, leukocyte count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: not specified
- Parameters checked: activity of cholinesterase and lactate dehydrogenase
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: not specified
- Dose groups that were examined: not specified
- Battery of functions tested: motor activity
Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
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:
not specified
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
HAEMATOLOGY: the effects on blood count were the limiting factors

CLINICAL CHEMISTRY: lactatedehydrogenase activity

Effect levels

open allclose all
Dose descriptor:
LOEC
Effect level:
20.5 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: haematology and activity of lactate dehydrogenase
Dose descriptor:
NOEC
Effect level:
5.5 mg/m³ air
Based on:
test mat.
Sex:
male
Basis for effect level:
other: haematology and activity of lactate dehydrogenase

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOEC and the LOEC of parachlorbenzotrifluorid to rats after 4 months of continuous exposure via inhalation are 5.5 mg/m3 and 20.5 mg/m3 respectively, based on effects on hematological parameters and on biochemistry parameters.
Executive summary:

The subchronic inhlation toxcity of parachlorbenzotrifluorid was studied in male rats exposed over a period of 4 months, 24 hours daily. 4 concentration levels + 1 negative control were tested and repeated measurements of a number of hematological and biochemistry parameters were made. The function of the central nervous system was also studied. The rat's body weight was not affected even at the highest concnetrations. The two top concentrations led to effects on almost the studied parameters. The lowest effective concentration was 20.5 mg/m3 and 5.5 mg/m3 was without effect. The effects on the blood count were the limiting factor.