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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986
Reference Type:
other: letter
Title:
Letter from E.I. du Pont de Nemours & Co Inc to US EPA regarding submission of studies using p-Fluorotoluene with attachments
Author:
TSCATS
Year:
1990
Bibliographic source:
Doc ID FYI-DTS-1090-0792, Microfiche No. OTS0000792

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Groups of 6 male Crl:CD BR rats were exposed to vapor atmospheres of fluorobenze for a single 4-hour period.
GLP compliance:
yes
Test type:
other: Inhalation Approximate Lethal Concentration procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorobenzene
EC Number:
207-321-7
EC Name:
Fluorobenzene
Cas Number:
462-06-6
Molecular formula:
C6H5F
IUPAC Name:
fluorobenzene
Details on test material:
- Name of test material (as cited in study report): Fluorobenzene
- CAS No.: 462-06-6
- Physical form: colourless liquid
- Purity: > 99%
- Supplier: Aldrich Chemical Co. Catalog No. F600-1
- Stability: The TS was assumed to be stable throughout the exposure phase of the test

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York
- Age at study initiation: 8 weeks
- Weight at study initiation: 229-269 g
- Housing: single housing in suspended, stainless steel, wire-mesh cages; during the test, rats were housed in pairs.
- Diet: Purina Certified Rodent Chow #5002 ad libitum (except during exposure)
- Water: ad libitum (except during exposure)
- Acclimation period: rats were quarantined for one week upon receipt; afterwards, they were held in stock for up to one week prior to testing

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
other: air
Details on inhalation exposure:
EXPOSURE PROTOCOL:
For each exposure, 6 rats were individually restrained in perforated, stainless steel cylinders with conical nose pieces. The restrainers were inserted into a face plate on the exposure chamber such that only-the nose of each rat protruded into the chamber. Each group of 6 rats was exposed nose-only for 4 continuous hours to a vapor atmosphere of fluorobenzene in air.

ATMOSPHERE GENERATION:
Vapor atmospheres of fluorobenzene were generated by pumping the liquid test material with a Harvard Model 975 Compact Infusion Pump into a 3-neck glass mixing flask. The flask was heated to 84-93°C with a Briskeat Model BC-170 heater to facilitate evaporation. The flask temperature was controlled with a Teco Model TC-1000 controller and was monitored with an Omega Type K Thermocouple Thermometer. Air introduced at the flask (approximately 22 L/min) swept the fluorobenzene vapors through a glass dispersion funnel and into the exposure chamber. Additional dilution air (approximately 1-18 L/min depending on desired concentration) was added to the vapor mixture prior to its entry into the chamber. The chamber exhaust was drawn through a dry ice cold trap and a MSA cartridge filter prior to being vented into the hood.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by gas chromatography approx. every 30 min during exposure
Duration of exposure:
4 h
Concentrations:
50, 520, 3700, 6200 and 10000 ppm
No. of animals per sex per dose:
6 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were weighed and observed prior to exposure. Group observations of clinical signs of toxicity were taken during each exposure and when rats were released from restrainers after exposure. Surviving rats were weighed and observed daily for 14 days post exposure, weekends and holidays included when warranted by the rats' condition.
- Necropsy of survivors performed: no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
other: Approximate Lethal Concentration
Effect level:
6 200 ppm
Exp. duration:
4 h
Remarks on result:
other: equivalent to 24.7 mg/L
Sex:
male
Dose descriptor:
LC50
Effect level:
> 6 200 ppm
Exp. duration:
4 h
Remarks on result:
other: equivalent to 24.7 mg/L
Mortality:
Two of 6 rats exposed to 6200 ppm and 5 of 6 rats exposed to 10,000 ppm died during exposure.
Clinical signs:
other: Please see any other information for description.
Body weight:
During the postexposure period, no significant weight loss or adverse clinical signs were observed in rats that survived exposure to fluorobenzene. No adverse clinical signs and average weight losses of 2% or less of initial body weight were observed in rats exposed to 50, 520 or 6200 ppm. Rats exposed to 3700 ppm were not weighed and observed one day after exposure. However, 3 of 6 rats had lost an average of 3% of initial body weight on the 2nd day post exposure, and no adverse clinical signs were observed. The one rat that survived exposure to 10,000 ppm had a dry red ocular discharge and lost 5% of initial body weight one day after exposure.

Any other information on results incl. tables

Concentration of fluorobenzene vapour atmospheres and rat mortality:













































Concentration (ppm)



Mortality


(# deaths/# exposed)



Mean



SD



Range



50



8.3



40-61



0/6



520



17



500-550



0/6



3700



1100



2000-6000



0/6



6200



630



5400-7400



2/6



10000



740



8800-11000



5/6



 


CLINICAL SIGNS


During or immediately following exposure, rats exposed to 50, 520 or 6200 ppm had red nasal or ocular discharges, effects common to rats under restraint. Rats exposed to 10,000 ppm had no response to sound during exposure. When released from restrainers after exposure, rats exposed to 3700 ppm and rats that survived exposure to 6200 or 10,000 ppm had rapid breathing, tremors, spasms, no righting reflex and clear oculardischarge.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The ALC for fluorobenzene was 6200 ppm (equally to 24.7 mg/L). The TS is considered to have very low toxicity on an acute inhalation basis (ALC > 5000 ppm).