Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible

Workers - Hazard for the eyes

Additional information - workers

Ethylene has been shown to cause subtle nasal effects (rhinitis) in rats in repeated high-exposure inhalation studies. These (and similar) effects have not been reported in humans. The relevance of the rat findings for humans is therefore questionable. Based upon the current animal data, a health-based reference concentration of approximately 50-75 ppm is suggested, i. e., significantly greater than current worker exposure levels. In the circumstances, a DNEL for ethylene is not being proposed. Whilst ethylene has been shown to have anaesthetic properties (at concentrations of 80%, equivalent dose 800,000 ppm or 917,857 mg/m3), the effect is at concentrations which far exceed occupational exposure levels and a clear NOAEC of 10,000ppm has been identified in studies in rats, therefore this should not drive DNEL derivation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Ethylene has been shown to cause subtle nasal effects (rhinitis) in rats in repeated high-exposure inhalation studies. These (and similar) effects have not been reported in humans. The relevance of the rat findings for humans is therefore questionable. Based upon the current animal data, a health-based reference concentration of approximately 50-75 ppm is suggested, i. e., significantly greater than current worker exposure levels. In the circumstances, a DNEL for ethylene is not being proposed. Whilst ethylene has been shown to have anaesthetic properties (at concentrations of 80%, equivalent dose 800,000 ppm or 917,857 mg/m3), the effect is at concentrations which far exceed consumer exposure levels and a clear NOAEC of 10,000ppm has been identified in studies in rats, therefore this should not drive DNEL derivation.