Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
7.964 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 674
Modified dose descriptor starting point:
T25
DNEL value:
13.33 mg/m³
AF for differences in duration of exposure:
0.4
Justification:
1/2.8, for adjustment of 7d/wk to 5d/wk, 48/52 wks, 40/75 yrs 1/2.8
AF for other interspecies differences:
2.5
Justification:
Guidance
AF for intraspecies differences:
5
Justification:
Guidance
AF for remaining uncertainties:
10
Justification:
Nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.2 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
938
Modified dose descriptor starting point:
other: LC50
Justification:
derive a NOAEC as starting point from the LC50

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:
DMEL (Derived Minimum Effect Level)
Value:
1.146 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
4 464
Modified dose descriptor starting point:
T25
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
655
Modified dose descriptor starting point:
NOAEL

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:
low hazard (no threshold derived)

Additional information - workers

1,2,3 -trichloropropane is deemed a potentiallyg enotoxic carcinogen (in vivo genotoxicity in question). Therefore the threshold values for acute toxicity were derived as DNELs assuming that a single exposure is not sufficient to cause a significant risk for carcinogenicity, while for long-term exposure DMELs were calculated based on the T25 value derived from the 2 year gavage carcinogenicity study by NTP (National Toxicology Program (1993) / Rats)

1,2,3-trichloropropane is handled as transported intermediate only, under strictly controlled conditions. Therefore under normal conditions repeated exposure is only expected via the inhalative route on a very low level. Only in cases of accidents, there might be acute exposure to higher amounts of the substance via the skin or the inhalation route.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.711 µg/m³
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
6 250
Modified dose descriptor starting point:
T25
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.05 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
1 574
Modified dose descriptor starting point:
NOAEC

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:
DMEL (Derived Minimum Effect Level)
Value:
0.205 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.19 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
2 080
Modified dose descriptor starting point:
NOAEL

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:
DMEL (Derived Minimum Effect Level)
Value:
0.205 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
DNEL related information
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.012 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10 000
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

1,2,3 -trichloropropane is deemed a potentially genotoxic carcinogen (even though the genotoxicity in vivo is in question). Therefore the threshold values for acute toxicity were derived as DNELs assuming that a single exposure is not sufficient to cause a significant risk for carcinogenicity, while for long-term exposure DMELs were calculated based on the T25 value derived from the 2 year gavage carcinogenicity study by NTP (National Toxicology Program (1993) / Rats)

1,2,3-trichloropropane is handled as transported intermediate only, under strictly controlled conditions. Therefore under normal conditions repeated exposure is only expected via the inhalative route on a very low level. Only in cases of accidents, there might be acute exposure to higher amounts of the substance via the skin or the inhalation route.