Registration Dossier

Administrative data

Description of key information

One study (reliability 2) on acute oral toxicity with the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane (purity 97%) is taken for evaluation. 
Existing data from an acute oral toxicity study (reliability of 2) with the surrogate substance 2-Perfluoralkylethyljodide (CAS no. 85995-91-1) are taken as supportive data for the evaluation because the main compound of this substance is the 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane with about 42 % . The remaining 60 % are fluorocarbon chains of different chain-length. Due to workplace safety aspects the read across to this substance was chosen to demonstrate that there is a similar toxicological behavior in the acute oral toxicity of both substances and to demonstrate the low potential of irritany of this substance class.
In order to determine the acute inhalation potential of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane (purity 97%) an acute inhalation toxicity study (reliability of 2) was available for evaluation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 868 mg/kg bw
Quality of whole database:
Study was performed in accordance or similar to OECD 401 and reliable with restrictions. Sufficiently documented study report with some details misssing as purity of substance, clinical signs of all animals. Study was performed prior to implementation of GLP.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
10 600 mg/m³
Quality of whole database:
Reliability 2. Sufficiently reported study with some details misssing as: batch number, purity of substance (but available in a pretest information) clinical signs of all animals and description of analytics to determine the concentrations of test item in air. The animal room temperature exceeds the required 22+/- 3°C. The study was performed prior to implementation of GLP.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

In order to evaluate the acute oral toxicity potential of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane a group of ten fasted rats per dose group (females) was given a single oral dose of test material via oral gavage. Study design was similar to the OECD 401 guideline. Dose levels of 3'200, 4'000, 5'000 and 8'000 mg/kg body weight were chosen with sesame oil as vehicle. During the observation period of 14 days post treatment no death occurred in the 3'200 mg/kg dose group. In the 4'000 mg/kg dose group 9 of 10 animals died, in the 5'000 mg/kg dose group 8 of 10 animals died and in the 8'000 mg/kg dose group 10 of 10 animals died.

In an OECD 401 study with the surrogate substance a limit dose of 5'000 mg/kg body weight in sesame oil was administered to 5 male and 5 female rats. Non mortality occurred during the study period. The acute oral median lethal dose (LD50) of the surrogate substance, was found to be greater than 5'000 mg/kg bw.

Based on the study results of the above mentioned studies with the 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane and the surrogate substance the acute oral median lethal dose (LD50) of the test material to the Wistar strain rat (females) was found to be 3'868 mg/kg body weight which is the worst case.

Inhalation:

In order to determine the acute inhalation potential of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane (purity 97%) 10 female rats per dose group were exposed to the test substance by nose-only inhalation for 4 hours. The aerosol concentration in air was 3'380, 10'328, 11'080, 11'150, 27'728 and 58'638 mg/m3, respectively. Based on this study the LC50 was determined to be 10'600 mg/m3(10'100 – 10'800 mg/m3).

Justification for classification or non-classification

According to the CLP regulation and based on the result obtained with the above mentioned studies the substance is not to classify.