Registration Dossier
Registration Dossier
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EC number: 219-514-3 | CAS number: 2451-62-9
Toxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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