Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
carcinogenicity
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
carcinogenicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
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:
no hazard identified
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Since 2 -methylbut-2-ene (2M2B) is concluded to be an in vivo mutagen (Cat 2, H341 under GHS/CLP) 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 2M2B is assigned the H-phrase H341 (suspected of causing genetic defects), 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:
high hazard (no threshold derived)
Most sensitive endpoint:
carcinogenicity
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
carcinogenicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
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:
no hazard identified
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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Since 2M2B is concluded to be an invivo mutagen (Cat 2, H341 under GHS/CLP)

with no relevant dose-response information and no cancer data, neither a DMEL nor a DNEL can be derived.

No consumer exposure is anticipated.