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Registration Dossier
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EC number: 202-486-1 | CAS number: 96-18-4
Toxicological Summary
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.
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