Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 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):
125
Dose descriptor starting point:
NOAEC
Value:
202 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
101 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans.

For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3

(according to eCHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans. For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3 (according to ECHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans. For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3 (according to ECHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans. For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3 (according to ECHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans. For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3 (according to ECHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

AF for dose response relationship:
1
Justification:
default assessment factor 1, because the starting point is a NOAEC, Chapter R 8.4.3.1
AF for differences in duration of exposure:
10
Justification:
According to Chapter 8, Table 8-5 the default assessment factor for subacute to chronic duration is 6. Taken into account a 15 day inhalation study, instead of a 28 day sub-acute study the AF for duration will be increased to 10.
AF for interspecies differences (allometric scaling):
1
Justification:
For an inhalation study already scaled according to the allometric principle, Chapter R 8.4.3.1
AF for other interspecies differences:
1
Justification:
A factor of 2.5 is suggested by the ECHA TGD for remaining interspecies differences, but justified deviations are possible. Rodents like the rat are in general more sensitive compared to humans as the rat's ventilation frequency is higher. Therefore, as a general rule a factor of 1 for remaining interspecies differences provides sufficient protection.
AF for intraspecies differences:
5
Justification:
default assessment factor for workers, Chapter 8.4.3.1
AF for the quality of the whole database:
1
Justification:
default assessment factor for good quality of the database, Chapter 8.4.3.1
AF for remaining uncertainties:
2.5
Justification:
additional factor according to Chapter R 8.4.3.1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.1 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):
12.5
Dose descriptor starting point:
NOAEC
Value:
202 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
101 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEC (inhalatory; rep. dose) was converted to a correction of the inhalation absorption in rats to the inhalation absorption in humans.

For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3

(according to ECHA Guidance, Chapter R8, Figure R.8). The corrected NOAEC is 101 mg/m3.

The NOAEC (inhalatory; rep. dose) was converted to a corrected NOAEC for the correction of the inhalation absorption in rats to the inhalation absorption in humans. For the correction the following calculation was applied: 202 mg/m3 x 0,75 x 0,67 = 101 mg/m3 (according to ECHA Guidance, Chapter R8, Figure R. 8). The corrected NOAEC is 101 mg/m3.

The

AF for dose response relationship:
1
Justification:
default assessment factor 1, because the starting point is a NOAEC, Chapter R 8.4.3.1
AF for interspecies differences (allometric scaling):
1
Justification:
already scaled according to the allometric principle, Chapter R 8.4.3.1
AF for other interspecies differences:
1
Justification:
A factor of 2.5 is suggested by the ECHA TGD for remaining interspecies differences, but justified deviations are possible. Rodents like the rat are in general more sensitive compared to humans as the rat's ventilation frequency is higher. Therefore, as a general rule a factor of 1 for remaining interspecies differences provides sufficient protection.
AF for intraspecies differences:
5
Justification:
default assessment factor for workers, Chapter 8.4.3.1
AF for the quality of the whole database:
1
Justification:
default assessment factor for good quality of the database, Chapter 8.4.3.1
AF for remaining uncertainties:
2.5
Justification:
additional factor according to Chapter R 8.4.3.1

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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information

Local effects

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

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:
no hazard identified
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:
no hazard identified
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:
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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route-extrapolation needed
AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
2
Justification:
An assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic to chronic (see section R 8.4.3.1, Table R.8-5) (ECHA, Nov. 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA TGD , the oral NOAEL for the rat in a first step is transferred to humans with a factor of 4 for allometric scaling (see Appendix R.8-2).
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies variability, the default assessment factor for general population is 10 (ECHA, Nov. 2012)
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter 8.4.3.1 of TGD (Echa, Nov. 2012)
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is exclusively used in chemical processes (i.e. a catalysator for industrial and professional use). A direct use of this substance is not known. The exposure of consumers to the substance is unlikely to occur via consumer products, because no consumer product is known to contain the substance. An exposure of consumers or general population via the environment is also unlikely to occur, because there are only low levels of exposure from environmental sources, and the substance released to the environment would rapidly be degraded by water and photooxidants. Therefore, DNELs for consumers or general population are not applicable as consumers are not involved in the industrial or professional use of 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid or of preparations containing this substance.

An indirect exposure of the general population via the environment might occur through ingestion of foodstuff or drinking water. Therefore, a systemic oral long-term DNEL for general population is derived and will be used to assess any possible risk that could result from indirect exposure of man via the environment.