Registration Dossier
Registration Dossier
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EC number: 204-126-9 | CAS number: 116-14-3
Endpoint summary
Administrative data
Description of key information
Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In accordance with section 2 of REACH Annex XI, studies on skin and eye irritation do not need to be conducted as the substance is a gas.
Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular irritation.
Justification for classification or non-classification
The gaseous state of TFE precludes the conduct of conventional skin and eye irritation studies in animals. Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular irritation. Therefore, classification for skin, eye and respiratory irritation is not warranted under EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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