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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.06 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: informed assessment factors
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
35.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL for developmental toxicity of 40 mg/kg bw/d

Modification of starting point involves conversion of rat oral exposure to human inhalation exposure using ECHA Ch R8, Fig. 8.3. Human NOAEC = Oral NOAEL X 1/0.38 m³/kg/d X 0.5 absn. Default X 6.7/10 = 35.3 mg/m³

AF for dose response relationship:
1
Justification:
Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation required, since the susceptible window is fully covered.
AF for interspecies differences (allometric scaling):
1
Justification:
default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
AF for other interspecies differences:
1
Justification:
Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required due to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
AF for intraspecies differences:
5
Justification:
default AF for workers; a combined interspecies and intraspecies assessment factor of 5 is using ECHA Ch R8, Characterisation of dose [concentration]-response for human health - Intraspecies differences, page 36.
AF for the quality of the whole database:
1
Justification:
The key studies were of high quality. No adjustment is required.
AF for remaining uncertainties:
1
Justification:
no 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 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: informed assessment factors
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL for developmental toxicity of 40 mg/kg bw/d

Modification of starting point involves conversion of rat oral exposure to human dermal exposure using ECHA Ch R8, Ex. B5, page 69. Human NOAEL = Oral NOAEL X 1 (Absorption factor for oral to dermal route =1; ECHA Ch R8. page 25.)

AF for dose response relationship:
1
Justification:
Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation required, since the susceptible window is fully covered.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to humans AF 4
AF for other interspecies differences:
1
Justification:
Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required due to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.)
AF for intraspecies differences:
5
Justification:
default AF (workers); a combined interspecies and intraspecies assessment factor of 5 is using ECHA Ch R8, Characterisation of dose [concentration]-response for human health - Intraspecies differences, page 36.
AF for the quality of the whole database:
1
Justification:
The key studies were of high quality. No adjustment is required.
AF for remaining uncertainties:
1
Justification:
no 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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.74 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: informed assessment factors
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
17.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL for developmental toxicity of 40 mg/kg bw/d

Modification of starting point involves conversion of rat oral exposure to human inhalation exposure using ECHA Ch R8, Fig. 8.3. Human NOAEC = Oral NOAEL X 1/1.15 m³/kg/d X 0.5 absn. = 17.4 mg/m³

AF for dose response relationship:
1
Justification:
Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation required, since the susceptible window is fully covered.
AF for interspecies differences (allometric scaling):
1
Justification:
default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
AF for other interspecies differences:
1
Justification:
Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.)
AF for intraspecies differences:
10
Justification:
default AF (general population); a combined interspecies and intraspecies assessment factor of 5 is using ECHA Ch R8, Characterisation of dose [concentration]-response for human health - Intraspecies differences, page 36.)
AF for the quality of the whole database:
1
Justification:
The key studies were of high quality. No adjustment is required.
AF for remaining uncertainties:
1
Justification:
no 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 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: informed assessment factors
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL for developmental toxicity of 40 mg/kg bw/d

Modification of starting point involves conversion of rat oral exposure to human dermal exposure using ECHA Ch R8, Ex. B5, page 69. Human NOAEC = Oral NOAEL X 1 (Absorption factor for oral to dermal route =1; ECHA Ch R8. page 25.)

AF for dose response relationship:
1
Justification:
Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation required, since the susceptible window is fully covered.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to humans AF 4
AF for other interspecies differences:
1
Justification:
Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
AF for intraspecies differences:
10
Justification:
default AF (general population); a combined interspecies and intraspecies assessment factor of 5 is using ECHA Ch R8, Characterisation of dose [concentration]-response for human health - Intraspecies differences, page 36.
AF for the quality of the whole database:
1
Justification:
The key studies were of high quality. No adjustment is required.
AF for remaining uncertainties:
1
Justification:
no 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 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: informed assessment factors
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

no route to route extrapolation required

AF for dose response relationship:
1
Justification:
Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
AF for differences in duration of exposure:
1
Justification:
No time extrapolation required, since the susceptible window is fully covered.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to humans AF 4
AF for other interspecies differences:
1
Justification:
Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
AF for intraspecies differences:
10
Justification:
default AF (general population); a A combined interspecies and intraspecies assessment factor of 5 is using ECHA Ch R8, Characterisation of dose [concentration]-response for human health - Intraspecies differences, page 36.
AF for the quality of the whole database:
1
Justification:
The key studies were of high quality. No adjustment is required.
AF for remaining uncertainties:
1
Justification:
no 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