Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
123 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Value:
1 234 mg/m³
Explanation for the modification of the dose descriptor starting point:
the NOAEL from the dermal study will be used for derivation of the inhalation DNEL because 1,2-hexanediol showed a high oral bioavailability. Even at the highest tested dermal dose of 1000 mg/kg/day no relevant systemic toxic effects were observed in the dermal 90-day study, and information on structurally related 1,2-alkanediols indicate NOAEL values of 1000 or higher in oral studies. Therefore no difference in systemic toxicity is to be expected after inhalation exposure. Moreover, the NOAEL of 700 mg/kg/day is considered conservative. As the oral bioavailability is high, no adjustment is done for extrapolation the bioavailability by inhalation. NOAEC = 700 mg/kg/day /0.38 m3/kg * 6.7 m3 / 10 m3 = 1234 mg/m3
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for airborne concentrations
AF for other interspecies differences:
1
Justification:
the remaining interspecies differences are considered to be low since 1,2-hexanediol is metabolized by enzymes, such as alcohol dehydrogenase, aldehyde dehydrogenase and glyoxylase that are present as housekeeping enzymes in all mammals and unlikely to show relevant species differences. Moreover, 1,2-hexanediol – apart from its slight local dermal irritation effects caused by a solvent-like effects that all alcohols have in common – showed no distinctive systemic toxicity: even at the highest dose of 1000 mg/kg/day no histopathological damage was observed for any internal tissue or organ.
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route extrapolation, similar dermal bioavailability is assumed for experimental animals and humans
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
1
Justification:
the remaining interspecies differences are considered to be low since 1,2-hexanediol is metabolized by enzymes, such as alcohol dehydrogenase, aldehyde dehydrogenase and glyoxylase that are present as housekeeping enzymes in all mammals and unlikely to show relevant species differences. Moreover, 1,2-hexanediol – apart from its slight local dermal irritation effects caused by a solvent-like effects that all alcohols have in common – showed no distinctive systemic toxicity: even at the highest dose of 1000 mg/kg/day no histopathological damage was observed for any internal tissue or organ.
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
Value:
609 mg/m³
Explanation for the modification of the dose descriptor starting point:
the NOAEL from the dermal study will be used for derivation of the inhalation DNEL because 1,2-hexanediol showed a high oral bioavailability. Even at the highest tested dermal dose of 1000 mg/kg/day no relevant systemic toxic effects were observed in the dermal 90-day study, and information on structurally related 1,2-alkanediols indicate NOAEL values of 1000 or higher in oral studies. Therefore no difference in systemic toxicity is to be expected after inhalation exposure. Moreover, the NOAEL of 700 mg/kg/day is considered conservative. As the oral bioavailability is high, no adjustment is done for extrapolation the bioavailability by inhalation. NOAEC = 700 mg/kg/day / 1.15 m3/kg = 609 mg/m3
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required for airborne concentrations
AF for other interspecies differences:
1
Justification:
the remaining interspecies differences are considered to be low since 1,2-hexanediol is metabolized by enzymes, such as alcohol dehydrogenase, aldehyde dehydrogenase and glyoxylase that are present as housekeeping enzymes in all mammals and unlikely to show relevant species differences. Moreover, 1,2-hexanediol – apart from its slight local dermal irritation effects caused by a solvent-like effects that all alcohols have in common – showed no distinctive systemic toxicity: even at the highest dose of 1000 mg/kg/day no histopathological damage was observed for any internal tissue or organ.
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route extrapolation, similar dermal bioavailability is assumed for experimental animals and humans
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
1
Justification:
mg/kg/day no histopathological damage was observed for any internal tissue or organ.
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
o the NOAEL from the dermal study will be used for derivation of the oral DNEL because 1,2-hexanediol showed a similar bioavailability after oral and dermal administration, even at the highest tested dermal dose of 1000 mg/kg/day no relevant systemic toxic effects were observed in the dermal 90-day study, and information on structurally related 1,2-alkanediols indicate NOAEL values of 1000 or higher in oral studies.
AF for dose response relationship:
1
Justification:
not required, starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor rat-human
AF for other interspecies differences:
1
Justification:
mg/kg/day no histopathological damage was observed for any internal tissue or organ.
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
not required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population