Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.052 mg/m³
Most sensitive endpoint:
genetic toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.052 mg/m³
Most sensitive endpoint:
genetic toxicity
DNEL related information
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
100
Dose descriptor starting point:
LOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 mg/kg bw/day
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
LOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: LOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Workers are dermally and by inhalation exposed to TGIC or TGIC containing powder coatings. The most sensitive route of exposure is considered to be by inhalation. TGIC has been classified as cat. II mutagen with a TLV (8 -hour-TWA) = 0.05 mg/m3 air, which is based in the genetic toxicity endpoint. The DNEL for dermal longterm exposure = 0.43 mg/kg bw is derived from a chronic toxicity study (oral) and thus, is very conservative, as the dermal exposure route is less sensitive than the oral route. The lowest short-term repeated-dose inhalation DMEL is calculated from a 5 -day inhalation mouse study, with special emphasis on mutagenic effects in the spermatogonial cells.

No long-term dermal or long-term inhalation experiments have been conducted with TGIC, and neither local nor systemic effects have been determined with the exception of the extrapolation from the long-term oral to long-term dermal study endpoints.

However, a long-term inhalation DNEL can be calculated from the oral one assuming an equal absorption rate of 100%. The value of 0.43 mg/kg bw (determined for the oral route) is multiplied by 60 (average minimal body weight of workers) and divided by 10 (m3 air consumed during a 8 -hour workshift), and adding an additional Safety Factor of 50 for change of exposure route and change from carcinogenic to mutagenic effects resulting in a DMEL = 0.052 mg/m3 air.

Thus, the occupational exposure limit set by the EU-commission (OSHA) is similar to the value derived from extrapolation of the oral long-term rat study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.005 mg/m³
Most sensitive endpoint:
genetic toxicity
DNEL related information
Overall assessment factor (AF):
5 000
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.002 mg/m³
Most sensitive endpoint:
genetic toxicity
DNEL related information
Overall assessment factor (AF):
1 000
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.01 mg/m³
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1 000
Dose descriptor starting point:
LOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.043 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.016 mg/kg bw/day
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1 000
Modified dose descriptor starting point:
LOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
1 000
Dose descriptor starting point:
other: LOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.043 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.096 mg/kg bw/day
Most sensitive endpoint:
genetic toxicity
DNEL related information
Overall assessment factor (AF):
1 000
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The general population is not exposed to TGIC or TGIC-containing mixtures. Nevertheless, DN(M)EL values for the general population can be calculated from the occupational ones by applying an additional safety factor.