Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Purity 99.0%
Impurities present:
3,3,3,4,4-pentafluoro-1-butene = 0.87%
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octene = 0.08%
1,1,1,2,2,3,3,4,4-nonafluoro-4-iodobutane = 0.004%

Test animals

Species:
rat
Strain:
other: Cr1 : CD
Sex:
male
Details on test animals and environmental conditions:
Young adult Crl : CD rats with average bodyweight of 242g.

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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).