Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
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:
insufficient hazard data available (further information necessary)
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:
medium hazard (no threshold derived)

Additional information - workers

The submission substance DMP Tech (reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol) is of low acute inhalation and oral toxicity; low acute dermal toxicity is therefore also assumed. No data are available for acute inhalation toxicity. The substance is not classified for skin irritation or corrosion and is not a skin senstiser, but is classified in Category 1 for eye irritation (Causes serious eye damage). No repeated dose toxicity data are available for the submission substance DMP Tech (reaction mass of 2-ethyl-2-(methoxymethyl)- propane-1,3-diol and 2-ethylpropane-1,3-diol); therefore the derivation of quantitative endpoints is not possible. Testing proposals are included in this dossier for a 90 -day oral toxicity in the rat and a pre-natal developmental toxicity study in the rat. Subject to approval of the testing proposals by ECHA, the results of these studies will enable the derivation of quantitative endpoints (DNELs). A qualitative risk assessment is currently proposed, in the absence of DNELs.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
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:
insufficient hazard data available (further information necessary)
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:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The submission substance DMP Tech (reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol) is of low acute inhalation and oral toxicity; low acute dermal toxicity is therefore also assumed. No data are available for acute inhalation toxicity. The substance is not classified for skin irritation or corrosion and is not a skin senstiser, but is classified in Category 1 for eye irritation (Causes serious eye damage). No repeated dose toxicity data are available for the submission substance DMP Tech (reaction mass of 2-ethyl-2-(methoxymethyl)- propane-1,3-diol and 2-ethylpropane-1,3-diol); therefore the derivation of quantitative endpoints is not possible. Testing proposals are included in this dossier for a 90 -day oral toxicity in the rat and a pre-natal developmental toxicity study in the rat. Subject to approval of the testing proposals by ECHA, the results of these studies will enable the derivation of quantitative endpoints (DNELs). A qualitatve risk assessment is currently proposed, in the absence of DNELs.