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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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
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
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
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
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
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