Registration Dossier
Registration Dossier
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EC number: 692-061-0 | CAS number: 1207435-39-9
Carcinogenicity
Administrative data
Description of key information
There are no studies concerning carcinogenicity of Fast Pyrolysis Bio-oil. Testing is not proposed, since testing in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Moreover, according to REACH Annex X section 8.9.1. a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the substance is classified as a germ cell mutagen category 2. The uses of Fast pyrolysis bio-oil (production, distribution and use as fuel) take place in closed systems and involve only accidental direct or indirect releases into environment or workplace air. According to ECHA guidance (R.8 p. 117), if there are indications of corrosivity, a substance would not be tested for systemic toxicity by any route of exposure. Fast pyrolysis bio-oil is classified as a human carcinogen (Carc.1B) based on the amount and classification of known components (formaldehyde).
The DNEL limit values for Fast Pyrolysis Bio-oil have been recalculated for maximum formaldehyde concentration of 5 % in FPBO. All the calculated DNEL values (inhalation/workers/acute, inhalation/workers/long-term, inhalation/general population/acute, inhalation/general population/long-term, oral/general population/long-term) are higher than the original DNEL values calculated for FPBO. Therefore, there is no need for risk assessment update based on formaldehyde content of FPBO.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There are no studies concerning carcinogenicity of Fast Pyrolysis Bio-oil. However, based on the amount and classification of known components classified as carcinogens (formaldehyde, Carc. 1B; < 0.5 %) Fast Pyrolysis Bio-oil should be classified as a human carcinogen.
Additional information
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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