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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Perfluorocarbons form a class of compounds with very similar propertioes with regards to living systems. They have been used in numerous medical applications, and so various studies have been performed by other parties and these have established how the materials behave

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
F2 Chemicals internal identifier: L40092

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
Acclimatised for at least five days prior, kept in air conditioned room at 20-24°C 24-60% humidity. Fed pelleted rodent diet and mains water; overnight fast before dosing.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no

Results and discussion

Preliminary study:
"The results of the rangefinding study indicated that 2000 mg/kg (the highest dose level of the fixed dose series) could be administrated without causing mortality."
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
None.
Body weight:
"Treatment with the test article produced no adverse effect on bodyweight gain in animals of either sex."
Gross pathology:
"There were no abnormal findings detected at necropsy in any animal."

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD Guidelines
Conclusions:
"A single administration of the test article, Flutec PC6 to a group of 5 male and 5 female rats, produced no apparent clinical signs of toxicity or deaths in animals of either sex. Both the discriminating dose and the minimum lethal oral dose of the test article are considered to be in excess of 2000 mg/kg bodyweight. ccording to criteria stated in guidelines, the test article, F~LUTEC PC6, would be considered not to have significant acute toxicity, under the conditions of this study.
Executive summary:

"A single administration of the test article, Flutec PC6 to a group of 5 male and 5 female rats, produced no apparent clinical signs of toxicity or deaths in animals of either sex. Both the discriminating dose and the minimum lethal oral dose of the test article are considered to be in excess of 2000 mg/kg bodyweight. According to criteria stated in guidelines, the test article, FLUTEC PC6, would be considered not to have significant acute toxicity, under the conditions of this study.