Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
Modified dose descriptor starting point:
T25
Value:
13.33 mg/m³
AF for dose response relationship:
25
Justification:
AF for T25
AF for differences in duration of exposure:
0.4
Justification:
1/2.8: for adjustment of 5d/wk to 7d/wk, 48/52 wks, 40/75 yrs
AF for interspecies differences (allometric scaling):
1
Justification:
included in respiration rate
AF for other interspecies differences:
2.5
Justification:
Guidance
AF for intraspecies differences:
5
Justification:
Guidance
AF for the quality of the whole database:
1
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
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
938
Modified dose descriptor starting point:
other: 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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
4 464
Dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
Modified dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
AF for dose response relationship:
25
Justification:
AF for T25
AF for differences in duration of exposure:
0.357
Justification:
1/2.8, for adjustment of 7d/wk to 5d/wk, 48/52 wks, 40/75 yrs
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
5
Justification:
default
AF for intraspecies differences:
2.5
Justification:
default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
655
Modified dose descriptor starting point:
other: LD50

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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 250
Dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
Modified dose descriptor starting point:
T25
Value:
4.44 mg/m³
AF for dose response relationship:
25
Justification:
AF for T25
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
included in repiratory volume
AF for other interspecies differences:
10
Justification:
default
AF for intraspecies differences:
2.5
Justification:
default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.05 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
Modified dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
AF for dose response relationship:
25
Justification:
AF for T25
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
10
Justification:
default
AF for intraspecies differences:
2.5
Justification:
default
AF for the quality of the whole database:
1
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.19 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Dose descriptor starting point:
T25
Value:
5.12 mg/kg bw/day
AF for dose response relationship:
25
Justification:
AF for T25
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
10
Justification:
default
AF for intraspecies differences:
2.5
Justification:
defgault
AF for the quality of the whole database:
1
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.012 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10 000

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.