[No public or meaningful name is available]

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliance , but no test guideline stated.

Data source

Reference

Reference Type:

other: inquiry result from ECHA

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: No test guideline stated in the report.

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-320-1

EC Name:

-

Cas Number:

690-39-1

Molecular formula:

C3H2F6

IUPAC Name:

1,1,1,3,3,3-hexafluoropropane

Test animals

Species:

other: Rat, Crl : CD BR

Administration / exposure

Route of administration:

inhalation

Vehicle:

other: Filtered, conditioned dilution air.

Details on inhalation exposure:

Method of exposure:
inhalation, whole body exposure
Mass median aerodynamic diameter:
not applicable

Duration of treatment / exposure:

Test duration: 90 days

Frequency of treatment:

Duration of exposure per day: 6 hours
Dosing regime: 5 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/l
Male: 5 animals at 5000 mg/l
Male: 5 animals at 20000 mg/l
Male: 5 animals at 50000 mg/l
Female: 5 animals at 0 mg/l
Female: 5 animals at 5000 mg/l
Female: 5 animals at 20000 mg/l
Female: 5 animals at 50000 mg/l

Results and discussion

Results of examinations

Details on results:

Clinical observations:
The substance had no effect on body weights, no abnormal clinical observations were seen in rats either prior to or following exposures.

The one notable compound-related effect was a diminished response to an alerting stimulus during exposure in the 50000 ppm male and female rats during the first week of the study. A diminished alerting response was noted in some rats primarily during the last two hours of the exposure. The number of rats affected generally decreased with sucessive exposures such that by study day 18, all rats from this group had a normal alerting response. All rats exhibited normal alerting response during the evaluation period immediately after exposure.

Laboratory findings:
No effect on the food consumption or food efficiency was observed.

Effects in organs:
No compound-related effects were detected during the ophthalmological and clinical pathology evaluations. No organ weight differences were seen during necropsy and no histopathologic changes were observed upon microscopic evaluation of tissues. No biologically significant alterations in hepatic peroxisomal á-oxidation activity were seen in any group.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

20 000 mg/L air

Basis for effect level:

other: exposure duration: 6 hours/day NOAEL=2000 ppm (124000 mg/m3)

2

Dose descriptor:

NOEC

Effect level:

20 000 mg/L air

Basis for effect level:

other: exposure duration: 6 hours/day NOAEL=2000 ppm (124000 mg/m3)

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Classified as: Not classified