Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
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:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
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

DNEL calculation:

Starting point: NOAEL 12 mg/kg/day; chronic 2 years study in rats; target organ: liver and adrenal

Assessment factors:

Interspecies difference:

Allometry: 4 (rat-humans)

Additional uncertainty: 1 (there is evidence that inter-species differences are covered in general by allometric scaling and no additional factor for remaining difference is necessary (Escher and Mangelsdorf 2010, ECETOC Report 2003, Draft ECETOC Report, 2010).

Route to route extrapolation:

Oral->dermal: 1

Oral->inhalation: 1 (TMQ is an organic solid pastille at room temperature with a melting point of 48°C (Currenta, 2010) and a very low vapour pressure <4.8 * 10-6 hPa at 25°C (Monsanto, 1980). Therefore inhalation exposure to vapour can be excluded. TMQ is a complex reaction mass (Mw approx. 500 g/mol) with partially undefined composition (UVCB). TMQ is expected to be mostly insoluble in water (Bayer AG, 1989); for general considerations see ECETOC Report, 2003; Draft ECETOC Report, 2010.

Severity of effects: 1 (liver is the target organ

Intraspecies factor: 3 for worker and 5 for the general population (ECETOC Report, 2003; Draft ECETOC Report, 2010).

Overall AF for dermal exposure or inhalation:

Worker: 4 x 3=12

General population: 4 x 5 = 20

DNELworker (long-term) dermal: 1 mg/kg

DNELworker (long-term) inhalation (70 kg body weight and 10 m3 air inhaled per 8 h shift): 7 mg/m3

DNELgeneral population (long-term) dermal: 0.6 mg/kg

DNELgeneral poplulation (long-term) inhalation (60 kg body weight and 20 m3 air inhaled per day): 1.8 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
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:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
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:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

See worker