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-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

Workers - Hazard for the eyes

Additional information - workers

Since isoamylene is concluded to be an in vivo mutagen (Cat 3, R68 under DSD) with no relevant dose-response information and no cancer data, neither a DMEL nor a DNEL can be derived.

 

A qualitative assessment is therefore considered. Since isoamylene is assigned the R-phrase R68 (possible risk of irreversible effects) it is allocated to the high hazard category on the basis that exposure to such substances should be strictly contained because they may cause serious health effects for which a dose threshold is not usually identifiable (TGD Section E.3.4)

 

With the strict control measures for a non-threshold mutagen, applying the RMMs/OCs as stipulated for the high hazard category, exposure control is considered to be sufficient and will cover any other relevant effects for which DNELs can be derived, for all routes of exposure.

 

In accordance with REACH guidance, it is concluded that this qualitative risk characterisation is sufficient and there is no need to conduct a quantitative risk characterisation.

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-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

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Additional information - General Population

Since isoamylene is concluded to be an invivo mutagen (Cat 3, R68 under DSD) with no relevant dose-response information and no cancer data, neither a DMEL nor a DNEL can be derived.

No consumer exposure is anticipated.