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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
11.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
279 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is required.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
The selected study is the most adequate and reliable study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for local effects
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
The selected study is the most adequate and reliable study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.58 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
158 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAELcorr = NOAECInhalatory × 0.38 m³/kg bw/day × (ABSinhal-rat/ABSdermal-human) × (6 h/8 h) = 555.3 mg/m³ × 0.38 m³/kg bw/day × (1/1) × 0.75 = 158.3 mg/kg bw/day. It is assumed that the inhalatory absorption rate is 100 % of that of the dermal absorption. ABSinhal-rat = inhalatory absorption rate in rats, ABSdermal-human = dermal absorption rate in humans.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers.
AF for the quality of the whole database:
1
Justification:
The selected study is the most adequate and reliable study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The DNEL (worker, inhalation, long-term) of 11.2 mg/m³ is in line with the occupational exposure limit of 9 mg/m³ (5 ppm) derived for formic acid by the Scientific Committee for Occupational Exposure Limits to Chemical Agents (SCOEL), and with the occupational exposure limit of 50 mg/m³ derived for glycerol (inhalable aerosol) derived by the DFG Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population

DNELs for the general population are not considered to be necessary since no risk characterisation is required, for the following reasons:

(1) The substance is intended for industrial uses only. Thus, any direct exposure of consumers via any route is not expected.

(2) Indirect oral exposure of the general public via the environment is not relevant according to the “Guidance on information requirements and chemical safety assessment Chapter R.16: Environmental Exposure Estimation”, section R.16.6.8.3. The guidance document states that assessment of indirect exposure is generally only conducted if (a) the tonnage is > 1,000 t/a or (b) the tonnage is > 100 t/a and the substance is classified as “Toxic” with a risk phrase “R48”, or as a carcinogen or mutagen (of any category), or as toxic to reproduction (category 1 or 2). Neither is the case for 1,2,3-propanetriol, mono- and diformates. Therefore, exposure of humans via the environment is irrelevant.