[No public or meaningful name is available]

Endpoint summary

Description of key information

Subchronic NOAEC (rat): 124000 mg/m3 (other guideline; GLP)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

other: No test guideline stated in the report.

GLP compliance:

yes

Limit test:

no

Species:

other: Rat, Crl : CD BR

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

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.

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)

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)

Critical effects observed:

not specified

Conclusions:

Classified as: Not classified

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEC

124 000 mg/m³

Study duration:

subchronic

Species:

rat

Quality of whole database:

Information from migrated NONS file, as per inquiry number 06-2120010181-80-0000, permission to refer granted by ECHA.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Inhalational Route:

One 90-day repeated dose toxicity study in the rat was available.

In the subchronic toxicity key study (other guideline, GLP), the substance was administered to Crl: CD BR rats (5/sex) by inhalation (whole body exposure; 6 h/day and 5 days/week for 90 days) at dose levels of 0, 5000, 20000, 50000 ppm.

There were no deaths during the study. There were no treatment-related effects (clinical signs, body weight, food consumption or food efficiency, ophthalmological and clinical pathology evaluations). There are no organ weight differences, histopathological changes or biologically significant alterations. The one notable substance-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. The NOAEL was 20000 ppm (124000 mg/m3) and the NOEC was 20000 ppm (124000 mg/m3).

One 2-week inhalation toxicity study in the rat was available.

In the subacute toxicity supporting study, the substance was administered to Crl:CD(r)BR rats (6 h/day and 5 days/week for 2 weeks) at dose level of 0, 5000, 20000, 50000 ppm.

There were no body weight effects and no abnormal clinical observations. The one notable substance-related effect was a diminished response or lack of response to an alerting stimulus during exposure (confined to mid- and high doses and resolved within second week of exposure). There were no organ weights differences, gross abnormalities or histopathological changes. The NOAEL was 5000 ppm.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

The study is GLP compliant and the method described is similar to the OECD 413 test guideline (Subchronic Inhalation Toxicity: 90-Day Study).

Justification for classification or non-classification

Based on the available information in the dossier, the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1)does not need to be classified for specific target organ toxicity (repeated) when considering the criteria outlined in Annex I of 1272/2008/EC.