Registration Dossier
Registration Dossier
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EC number: 216-629-0 | CAS number: 1630-78-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - workers
The hazard assessement for workers have been based on a qualitative 'high hazard' based on genetic toxicity as the most sensitive endpoint for the substance and that the substance may be an in-vivo mutagen, as a worst case assessment.
However, it should also be noted that a Workplace Environmental Exposure Level (WEEL) has also been derived by the Workplace Environmental Exposure Level (WEEL) Committee:
Workplace Environmental Exposure Level (WEEL) Committee, Occupational Alliance for Risk Science (OARS), and Toxicology Excellence for Risk Assessment (TERA). "(E)-1, 2-Difluoroethylene (HFO-1132E)." Toxicology and Industrial Health 38, no. 8 (2022): 435-443.
A 8-h time-weighted average (TWA) WEEL value of 350 ppm was derived (equivalent to 916 mg/m3).
The key study for the WEEL was the 13-week inhalation toxicity study. The inhalation NOAEC (15,000 ppm) as adjusted to account for exposure duration and also by application of appropriate uncertainty factors to account for interindividual variability, subchronic to chronic exposure, uncertainty regarding genotoxicity results and lack of metabolism data.
The WEEL value of 350 ppm is expected to provide a significant margin of safety against any potential adverse health effects in workers (including genotoxic effects, as the in-vivo studies were conducted at comparatively high concentrations in relation to repeat dose studies and the derived WEEL).
A short-term exposure level (STEL) or skin notation was not considered applicable.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- genetic toxicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
See comments on WEEL in workers section. Although the WEEL is derived for workers, it may be used also as an indication for consumers.
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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