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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
8.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
661 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the oral rat OECD 422 screening study with 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether.  A corrected starting point (inhalation NOAEC) of 661 mg/m3 is calculated based on activity (*6.7/10) and breathing rate (/0.38), and taking into account assumptions relating to the relative extent of oral (50%) and inhalation absorption (100%).  

AF for dose response relationship:
1
Justification:
Default value; the starting point is derived from a NOAEL
AF for differences in duration of exposure:
6
Justification:
Default value to cover extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
An assessment factor for allometric scaling is not required: allometric differences are already accounted for in the derivation of the corrected (inhalation) starting point
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value: a good quality database is available for APE
AF for remaining uncertainties:
1
Justification:
Default value: there are no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
DNEL (Derived No Effect Level)
Value:
2.5 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):
300
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the oral rat OECD 422 screening study with 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether.  In the absence of data on the extent of dermal absorption, this is assumed to be equivalent to oral absorption (worst case default).  A corrected dermal starting point (NOAEL) of 750 mg/kg bw/d is therefore calculated.  

AF for dose response relationship:
1
Justification:
Default value: the starting point is derived from a NOAEL
AF for differences in duration of exposure:
6
Justification:
Default value to take into account extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: the starting point is derived from a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value: a good quality database is available
AF for remaining uncertainties:
1
Justification:
Default value: there are no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
no hazard identified

Additional information - workers

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute oral toxicity, is not classified for skin or eye irritation or for skin sensitisation. The substance is not mutagenic based on studies in vitro. An OECD 422 (sub-acute, oral) screening study performed in the rat reports a NOAEL of 750 mg/kg bw/d.  The NOAEL of 750 mg/kg bw/d from the (sub-acute, oral) screening study is therefore the relevant starting point for DNEL derivation.

Worker DNEL derivation

Inhalation DNELs

Systemic inhalation DNELs

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the rat oral (sub-acute) OECD 422 screening study. A corrected starting point (inhalation NOAEC) of 661 mg/m3 can be calculated based on activity (*6.7/10) and breathing rate (/0.38), and for the relative extent of oral (50%) and inhalation absorption (100%). Individual assessment factors of 1 (for dose-response relationship), 6 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining differences) are used, resulting in an overall assessment factor of 75. Application of the overall assessment factor to the corrected starting point results in a long-term systemic inhalation DNEL of 8.8 mg/m3. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute toxicity and is not classified for acute toxicity. In the absence of any identified hazard, an acute systemic inhalation DNEL is not proposed.

Local inhalation DNELs

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is not an irritant or sensitiser; therefore local effects on the repiratory tract are not predicted.  Local inhalation DNELs are not proposed in the absence of any identified hazard.

Dermal DNELs

Systemic dermal DNELs

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the oral rat (sub-acute) OECD 422 screening study. In the absence of data on the extent of dermal absorption, this is assumed to be equivalent to oral absorption (worst case default). A corrected dermal starting point (NOAEL) of 750 mg/kg bw/d is calculated. Individual assessment factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences), 1 (for database quality) and 1 (for remaining differences) are used, resulting in an overall assessment factor of 300. Application of the overall assessment factor to the corrected starting point results in a long-term systemic dermal DNEL of 2.5 mg/kg bw/d. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether

is of low acute toxicity and is not classified for acute toxicity. In the absence of any identified hazard, an acute systemic dermal DNEL is not proposed.

Local dermal DNELs

1,3-propanediol, 2,2 - bis(hydroxymethyl) -, allyl ether is not a skin irritant or sensitiser; therefore local dermal effects are not predicted. Local dermal DNELs are not proposed in the absence of any identified hazard.

Hazard for the eyes

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether

is not classified as an eye irritant. No hazard is identified.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
326 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the oral rat (sub-acute) OECD 422 screening study.  A corrected starting point (inhalation NOAEC) of 326 mg/m3 can be calculated based on breathing rate (/1.15) and taking into account assumptions relating to the relative extent of oral (50%) and inhalation absorption (100%).  

AF for dose response relationship:
1
Justification:
Default value: the starting point is derived from a NOAEL
AF for differences in duration of exposure:
6
Justification:
Default value to cover extrapolation from a sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
An assessment factor to cover allometric factors is not required: allometric factors are already taken into acount in derivation of the corrected starting point
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Default value: a good quality dataset is available for 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether
AF for remaining uncertainties:
1
Justification:
Default value: there are no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
DNEL (Derived No Effect Level)
Value:
1.3 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):
600
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the rat oral (sub-acute) OECD 422 screening study.  In the absence of data on the extent of dermal absorption, this is assumed to be equivalent to oral absorption (worst case default).  A corrected dermal starting point (NOAEL) of 750 mg/kg bw/d is therefore calculated.

AF for dose response relationship:
1
Justification:
Default value: the starting point is derived from a NOAEL
AF for differences in duration of exposure:
6
Justification:
Default value to cover extrapolation from sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: the starting point is derived from a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Default value: a good quality database is available for 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether
AF for remaining uncertainties:
1
Justification:
Default value: there are no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
DNEL (Derived No Effect Level)
Value:
1.3 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):
600
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction of the starting point is not required as this is derived from an oral study.

AF for dose response relationship:
1
Justification:
Default value: the starting point is an AOEL
AF for differences in duration of exposure:
6
Justification:
Default value to cover extrapolation from sub-acute study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: the starting point is derived from a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Default value: a good quality database is available
AF for remaining uncertainties:
1
Justification:
Default value: there are no significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute oral toxicity, is not classified for skin or eye irritation or for skin sensitisation. The substance is assumed not to be mutagenic based on studies in vitro. A sub-acute oral rat OECD 422 screening study reports a NOAEL of 750 mg/kg bw/d. The NOAEL of 750 mg/kg bw/d from the screening sudy is therefore the relevant starting point for DNEL derivation.

General Population DNEL derivation

Inhalation DNELs

Systemic inhalation DNELs

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the (sub-acute) oral rat OECD 422 screening study. A corrected starting point (inhalation NOAEC) of 326 mg/m3 can be calculated based on breathing rate (/1.15), and for the relative extent of oral (50%) and inhalation absorption (100%). Individual assessment factors of 1 (for dose-response relationship), 6 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining differences) are used, resulting in an overall assessment factor of 150. Application of the overall assessment factor to the corrected starting point results in a long-term systemic inhalation DNEL of 2.2 mg/m3. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute oral toxicity and is not classified for acute toxicity. In the absence of any identified hazard, an acute systemic inhalation DNEL is not proposed.

Local inhalation DNELs

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is not an irritant or sensitiser; therefore local effects on the respiratory tract are not predicted. Local inhalation DNELs are not proposed in the absence of any identified hazard.

Dermal DNELs

Systemic dermal DNELs

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the (sub-acute) oral rat OECD 422 screening study. In the absence of data on the extent of dermal absorption, this is assumed to be equivalent to oral absorption (worst case default). A corrected dermal starting point (NOAEL) of 750 mg/kg bw/d is therefore calculated.  Individual assessment factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining differences) are used, resulting in an overall assessment factor of 600. Application of the overall assessment factor to the corrected starting point results in a long-term systemic dermal DNEL of 1.3 mg/kg bw/d. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute oral toxicity and is not classified for acute toxicity.  Low acute dermal toxicity is assumed. In the absence of any identified hazard, an acute systemic demral DNEL is not proposed.

Local dermal DNELs

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is not a skin irritant or sensitiser; therefore local dermal effects are not predicted. Local dermal DNELs are not proposed in the absence of any identified hazard.

Oral DNELs

The relevant starting point is the NOAEL of 750 mg/kg bw/d from the (sub-acute) oral rat OECD 422 screening study. Correction of the starting point is not required. Individual assessment factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences), 1 (for database quality) and 1 (for remaining differences) are used, resulting in an overall assessment factor of 600. Application of the overall assessment factor to the starting point results in a long-term systemic oral DNEL of 1.3 mg/kg bw/d. 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is of low acute oral toxicity and is not classified for acute toxicity. In the absence of any identified hazard, an acute systemic oral DNEL is not proposed.

Hazard for the eyes

1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is not classified as an eye irritant. No hazard is identified.