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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.4 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):
50
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL for 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol which is based upon a combined 28-day oral + reproduction/developmental toxicity screening (OECD 422). The NOAEL was established to 300 mg/kg bw/day. Therefore the corrected NOAEC is: NOAEL*(1/0.38)*(1/2)*(6.7/10)*1.4 = 370 mg/m3.

1/0.38 : standard respiratory volume

1/2 : factor 2route extrapolation from oral to inhalation

6.7/10 : differences of respiratory volume general population (8h)/ workers (8h)

7/5 :correction for differences in exposure schemes

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6, and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining differences.
AF for intraspecies differences:
5
Justification:
A factor of 5 is applied for workers
AF for the quality of the whole database:
1
Justification:
The key study chosen for DNEL calculation is considered as a reliable study.
AF for remaining uncertainties:
1
Justification:
no additional factor.
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:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL for 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol which is based upon a combined 28-day oral + reproduction/developmental toxicity screening (OECD 422). The NOAEL was established to 300 mg/kg bw/day. When applying the correction for differences between human and experimental exposure conditions (workers), the corrected NOAEL is : 300 x 1.4 = 420 mg/m3.

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL.
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6, and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining difference.
AF for intraspecies differences:
5
Justification:
A factor of 5 is applied for worker DNELs.
AF for the quality of the whole database:
1
Justification:
The key study chosen for DNEL calculation is considered as a reliable study.
AF for remaining uncertainties:
1
Justification:
no additional factor
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:
1.3 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):
100
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL for 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol which is based upon a combined 28-day oral + reproduction/developmental toxicity screening (OECD 422). The NOAEL was established to 300 mg/kg bw/day. Therefore the corrected NOAEC is: NOAEL*(1/1.15)*(1/2) = 130 mg/m3.

1/1.15: standard respiratory volume

1/2: factor 2route extrapolation from oral to inhalation

AF for dose response relationship:
1
Justification:
Starting poing is a NOAEL
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6 and a factor of 2 for a 90-day study. In an OECD 422 study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining differences.
AF for intraspecies differences:
10
Justification:
A factor of 10 is applied for general population.
AF for the quality of the whole database:
1
Justification:
The key study chosen for DNEL calculation is considered as a reliable study.
AF for remaining uncertainties:
1
Justification:
no additional factor
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:
0.75 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):
400
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL for 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol which is based upon a combined 28-day oral + reproduction/developmental toxicity screening (OECD 422). The NOAEL was established to 300 mg/kg bw/day. No correction factor should have to be applied.

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use a factor of 6 and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining differences.
AF for intraspecies differences:
10
Justification:
A factor of 10 is applied for general population.
AF for the quality of the whole database:
1
Justification:
The key study chosen for DNEL calculation is considered as a reliable study
AF for remaining uncertainties:
1
Justification:
No additional factor
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:
0.75 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):
400
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point is the NOAEL for 2,2'-isopropylidenebis(p-phenyleneoxy)diethanol which is based upon a combined 28-day oral + reproduction/developmental toxicity screening (OECD 422). The NOAEL was established to 300 mg/kg bw/day. No correction factor should have to be applied.

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL.
AF for differences in duration of exposure:
4
Justification:
DNEL is based on an OECD 422 study. For an exposure of 28-day, ECHA recommends to use of 6 and a factor of 2 for a 90-day study. In an OECD 422 study, rats were exposed approx. 6 weeks, thus a factor of 4 is appropriate.
AF for interspecies differences (allometric scaling):
4
Justification:
A defeult factor for allometric scaling is 4 for rat to human.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is applied for remaining differences
AF for intraspecies differences:
10
Justification:
A factor of 10 is applied for general population.
AF for the quality of the whole database:
1
Justification:
The key study chosen for DNEL calculation is considered as a reliable study.
AF for remaining uncertainties:
1
Justification:
No additional factor
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