Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The prediction indicates that the studied compound is identified as a potential mutagen causing chromosome-type aberrations.

Based on the observed results, the No Observed Adverse Effect Level (NOAEL) of test item 3-(isodecyloxy)propylammonium acetate is 50 mg/kg body weight/day when administered for a period of 28 consecutive days by oral (gavage) route to Sprague Dawley rats under the test conditions employed.

Based on the results, the No Observed Adverse Effect Level (NOAEL) of 3-(isopropyl) ammonium acetate was found to be 125 mg/kg body weight, the mid dose when administered to the males for two weeks pre-mating, during mating and up to the day before sacrfice during post-mating period (total of 39 days), to the females for two weeks pre-mating, during mating, pregnancy (gestation) an up to lactation day 13, under experimental conditions employed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Substance is classified as Skin Corr.1B, H314. According to Annex VII, Column B: The study/ies do(es) not generally need to be conducted it the substance is calssified as skin corrosion.

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
50 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
125 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population