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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline available
Guideline:
other:
Principles of method if other than guideline:
No guideline available
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Cr1 : CD
Sex:
male
Details on test animals or test system and environmental conditions:
Young adult Crl : CD rats with average bodyweight of 242g.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material, which was used as received, was administered by intragastric intubation in single doses to a group of 10 young adult Cr1 : CD ® male rats. A range finding study was first conducted in the range 670 - 25000 mg/kg bw to determine the initial dose level for the LD50 test. There were no deaths in the range finding study, so a dose level of 25000 mg/kg bw was selected. Surviving male rats administered 25000 mg/kg bw in the LD50 test were weighed and observed during a 14-day recovery period, and then sacrificed.
Doses:
25000 mg/kg bw
No. of animals per sex per dose:
10 males
Sex:
male
Dose descriptor:
LD50
Effect level:
> 25 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10
Clinical signs:
congestion and slight weight loss in one rat
Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) in the rat is greater than 25000 mg/kg bw.
Executive summary:

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) has very low toxicity when administered orally to young adult Crl : CD male rats in single doses. Its LD50 is greater than 25000 mg/kg bw, the maximum feasible dose. There was no mortality, and the only clinical signs observed were congestion and slight weight loss in one rat (out of ten on test).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
25 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) has very low toxicity when administered orally to young adult Crl : CD male rats in single doses. Its LD50 is greater than 25000 mg/kg bw, the maximum feasible dose. There was no mortality within the 14 -day observation period and the only clinical signs observed were congestion and slight weight loss in one rat (out of ten on test).

In a sub-acute toxicity study with PFBE in the rat conducted to OECD 412 no treatment related mortality was observed in animals exposed upto 10,000 ppm (100615 mg/m3) for 6 hrs/day for 28 days. Based on this it can be said that the 4hr LC50 (rat) of PFBE will be > 100.6 mg/l, well in excess of the EU upper regulatory limit of 20mg/l for classification for acute toxicity by inhalation.


Justification for selection of acute toxicity – oral endpoint
Standard acute oral toxicity test

Justification for selection of acute toxicity – inhalation endpoint
In a sub-acute toxicity study with PFBE in the rat conducted to OECD 412 no treatment related mortality was observed in animals exposed upto 10,000 ppm (100615 mg/m3) for 6 hrs/day for 28 days. Based on this it can be said that the 4hr LC50 (rat) of PFBE will be > 100.6 mg/l, well in excess of the EU upper regulatory limit of 20mg/l for classification for acute toxicity by inhalation.

Justification for classification or non-classification

In a standard acute oral toxicity test, the LD50 of PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) in the rat was judged to be > 25000 mg/kg bw. Therefore, as the LD50 is well in excess of 2000 mg/kg bw, classification for acute toxicity by the oral route is not warranted according to EU Directive 67/548/EEC or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

In a sub-acute toxicity study with PFBE in the rat conducted to OECD 412 no treatment related mortality was observed in animals exposed upto 10,000 ppm (100615 mg/m3) for 6 hrs/day for 28 days. Based on this it can be said that the 4hr LC50 (rat) of PFBE will be > 100.6 mg/l, well in excess of the EU upper regulatory limit of 20mg/l for classification for acute toxicity by inhalation. Therefore, classification for acute toxicity by the inhalation route is not warranted according to EU Directive 67/548/EEC or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.