2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2022

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

EC Number:

639-791-8

Cas Number:

3345-29-7

Molecular formula:

C16H8F8

IUPAC Name:

2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

Specific details on test material used for the study:

Batch n. 340421
Date of analysis 26 November 19, 2021
Purity ≥98.00%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period.
Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All
animals were necropsied and examined macroscopically.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

2000 mg/kg body weight
The test item was dissolved in corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the end of the study without showing any test-item related signs of toxicity

Gross pathology:

At necropsy, no macroscopic findings were observed in any animal of any step.

Any other information on results incl. tables

The piloerection observed on day 1 in animals of the 1th and 2nd step was not considered to be related
to the test item but to the administration procedure and the possible stress induced. No further clinical
signs were observed in these animals until the end of the observation period.
Throughout the 14-day observation period, the weight gain of the animals was within the normal range
of variation for this strain.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item PARYLENE HT®
to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.
The median lethal dose of PARYLENE HT® after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/kg bw