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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
DNEL value:
29.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As in the 90d-inhalation toxicity study with N-Vinylcaprolactam (BASF AG, 1995) the same NOAEC was observed as in the the 28d-inhalation toxicity study (BASF SE, 2013), the use of the default extrapolation factor for exposure duration of 2 (subchronic-to-chronic) is justified.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not applied, because the ventilation rate directly depends on the basal metabolic rate.
AF for other interspecies differences:
1
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
3
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach of the DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
When comparing subacute to chronic exposure duration, irritation responses are considered to be mostly concentration dependent; no duration-based difference between subchronic and chronic exposure is assumed.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not applied.
AF for other interspecies differences:
1
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
3
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach of the DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
DNEL value:
16.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by the dermal route.
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As in the 90d-inhalation toxicity study with N-vinylcaprolactam (BASF AG, 1995) the same NOAEC was observed as in the the 28d-inhalation toxicity study (BASF SE, 2013), the use of the default extrapolation factor for exposure duration of 2 (subchronic-to-chronic) is justified.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Interspecies differences are fully covered by the allometric scaling. The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
3
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
10.4 mg/m³
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As in the 90d-inhalation toxicity study with N-Vinylcaprolactam (BASF AG, 1995) the same NOAEC was observed as in the the 28d-inhalation toxicity study (BASF SE, 2013), the use of the default extrapolation factor for exposure duration of 2 (subchronic-to-chronic) is justified.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not applied, because the ventilation rate directly depends on the basal metabolic rate.
AF for other interspecies differences:
1
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
5
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
1
Justification:
When comparing subacute to chronic exposure duration, irritation responses are considered to be mostly concentration dependent; no duration-based difference between subchronic and chronic exposure is assumed.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not applied.
AF for other interspecies differences:
1
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
5
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
16.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by the dermal route.
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As in the 90d-inhalation toxicity study with N-Vinylcaprolactam (BASF AG, 1995) the same NOAEL was observed as in the the 28d-inhalation toxicity study (BASF SE, 2013), the use of the default extrapolation factor for exposure duration of 2 (subchronic-to-chronic) is justified.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Interspecies differences are fully covered by the allometric scaling. The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
5
Justification:
The DNEL is derived from the most sensitive endpoint (cell proliferation) with the lowest NOAEC observed in a mechanistic study. There is no evidence of a high variability for this effect within human populations. Thus, the (ECETOC) default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
6
Justification:
The default extrapolation factor for exposure duration is used: sub-acute (starting point) to chronic (end point).
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Interspecies differences are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics (ECETOC). Therefore, no additional factor is used.
AF for intraspecies differences:
5
Justification:
The (ECETOC) default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population