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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
Study period:
4-hr
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Due to low toxicity only two high exposure levels were used
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch ATOCHEM NA Batch PB 38, filling number 3777/91, purity 99.8%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male rats 7 wks of age (133-147 gm) and female rats 10 wks of age (172 to 179 gm) were obtained from Charles River, Margate, England. They were housed 5/cage in high density polypropylene cages 56 x 38 x 18 cm. Fresh outside air was conditioned to target temperature (18-25 deg. C) and humidity (40-70%). Rats were given tap water and LAD 1 pelleted rodent diet. Animals were observed daily for 7 days before exposure. At the time of exposure male body weights were 209 to 233 gm and female body weights were 203 to 225 gm.

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The exposure chamber was a 30 cm cylinder with an internal volume of 40 l. Rats were placed in the polycarbonate restraining tubes and attached to the exposure cylinder. Due to the high exposure levels oxygen was added to the air to maintain oxygen levels at 20%.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
By gas chromatography using a gas sampling loop at least 5 times during the exposure.
Duration of exposure:
4 h
Concentrations:
0 (control), 305000 and 591000 ppm
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Details on study design:
The rats were observed during the exposure and for 14 days post exposure. At the end of the 14 days, they were sacrificed and a gross necropsy examination was preformed. Lung, liver and kidney weights were measured and the larynx, lings, liver and kidneys preserved in NBF.
Statistics:
mean body weights and organ weights were calculated with standard deviations.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 591 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
none
Clinical signs:
There were no deaths. There were no clinical signs that appeared related to the exposures.
Body weight:
On the day following the exposure slight body weight depressions were noted in control and Forane 143a exposed rats. These were consistent with the type of restraint (tubes) used during the exposure. Subsequently body weights were normal.
Gross pathology:
There were no macroscopic findings that were attributed to the exposure.
Other findings:
Analysis of organ weight data did not show evidence for treatment related effects.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Exposures up to 591000 ppm for 4 hrs did not result in mortality or even significant signs of toxicity.
Executive summary:

Groups of 5 male and 5 female rats were exposed nose only to vapors of Forane 143a at levels of 0 (control), 310000 or 591000 ppm for 4 hrs. There were no significant clinical signs or effects on body weight or organ weights or gross necropsy observations that appeared to be related to the exposures.