Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
540
Modified dose descriptor starting point:
LOAEC
DNEL value:
110 mg/m³
Explanation for the modification of the dose descriptor starting point:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Figure R.8-3, Modification of thee starting point:, page 27.
Justification:
None required as per ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Figure 8-3, page 27.
AF for differences in duration of exposure:
20
Justification:
Worker exposure is 8 hr/ rabbit exposure 4 hr = 2-fold and acute to chronic adjustment = 10-fold based upon Expert judgement
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Figure R.8-3, Modification of the starting point: page 27.
Justification:
Corrosion is a direct acting local effect, therefore no Assessment Factor is required as per ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Local effect, page 33.s
AF for intraspecies differences:
3
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Quality of whole database, pages 36-37.
AF for remaining uncertainties:
3
Justification:
LOAEL to NOAEL as per ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, page 36.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
54
Modified dose descriptor starting point:
LOAEC
DNEL value:
110 mg/m³
Explanation for the modification of the dose descriptor starting point:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Figure r.8-3 Modification of the starting point: page 27.
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL, as per “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, page 36.
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Modification of starting point, page 27.
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Local effects, page 33.
AF for intraspecies differences:
3
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Quality of whole database, page 37./
AF for remaining uncertainties:
2
Justification:
Exposure duration adjustment, Worker 8 hr/Rabbit 4 hr = 2-fold.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL, as per the ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, page 36.
AF for differences in duration of exposure:
20
Justification:
Worker 8 hr exposure/rabbit 4 hr exposure = 2-fold and acute to chronic = 10-fold based on Expert Judgement.
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Local effects, page 33.
AF for intraspecies differences:
3
Justification:
“Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Table R.8-19, pages 76-77.
Justification:
DNEL is for Local effects (corrosion) only.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
18
Dose descriptor starting point:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL, “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, page 36
Justification:
Direct local effect, no AF required as per ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, pages 32-33.
Justification:
Local direct effect, none required, ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, pages 32-33.
AF for intraspecies differences:
3
Justification:
Worker, ECHA “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health”, Tabler.8-19, pages 76-77.
Justification:
DNEL is derived for Local effects (crossion) only.
AF for remaining uncertainties:
2
Justification:
Exposure duration, 8 hr worker/4 hr rabbit = 2-fold.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.385 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 300
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, R.8.4.3.1. Tables R.8-3 and R.8-4, pages 30 and 32. d 32.
AF for dose response relationship:
3
Justification:
E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, LOAEL to NOAEL, Section R.8.4.3.1. page 36.
AF for differences in duration of exposure:
20
Justification:
8 hr Worker exposure/4 hr rabbit exposure = 2-fold and acute exposure to chronic exposure = 10-fold (Expert judgement).
AF for interspecies differences (allometric scaling):
2.4
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section 8.4.3.1. Table R.8-3, page 30.
Justification:
Adverse effect is direct acting (skin corrosion) as per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 33.
AF for intraspecies differences:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health,Appendix, Table R.8-19, pages 76-77. .
AF for the quality of the whole database:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 36-37.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.85 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
130
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, R.8.4.3.1. Tables R.8-3 and R.8-4, pages 30 and 32.
AF for dose response relationship:
3
Justification:
E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, LOAEL to NOAEL, Section R.8.4.3.1. page 36.
AF for interspecies differences (allometric scaling):
2.4
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section 8.4.3.1. Table R.8-3, page 30.
Justification:
Adverse effect is direct acting (skin corrosion) as per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 33.
AF for intraspecies differences:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health,Appendix, Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 36-37.
AF for remaining uncertainties:
2
Justification:
Duration of exposure, Worker 8 hr/4 hr rabbit = 2-folds.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.28 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
AS per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 36 and Appendix R.8-10, page 128.
AF for differences in duration of exposure:
10
Justification:
Acute exposure to chronic (Expert judgement)
Justification:
As per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 32-33.
AF for intraspecies differences:
3
Justification:
As per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Appendix R.8-3, pages 76-77.
Justification:
DNEL is for protection from sensitisation.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
9
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
AS per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 36 and Appendix R.8-10, page 128.
Justification:
As per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 32-33.
AF for intraspecies differences:
3
Justification:
As per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Appendix R.8-3, pages 76-77
Justification:
DNEL is for protection from sensitisation.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

The DNELs derived for the workforce are primarily to protect from the corrosive/irritating nature of the test substance and its potential to induce a skin sensitisation state.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
7.72 µg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 480
Modified dose descriptor starting point:
LOAEL
DNEL value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1, pages 30-31.
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL as per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 36.
AF for differences in duration of exposure:
60
Justification:
24 hr General Population/4 hr rabbit = 6-fold plus Acute to chronic exposure = 10-fold (Expert Judgement).
AF for interspecies differences (allometric scaling):
2.4
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 30 and 32.
AF for intraspecies differences:
5
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 36-37.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.72 µg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 480
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.167 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1 page 36.
AF for differences in duration of exposure:
10
Justification:
acute to chronic exposure = 10-fold (Expert Judgement).
Justification:
As per As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. pages 32-33.
AF for intraspecies differences:
5
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, pages 76-77.
Justification:
DNEL is protective only for skin sensitisation.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.167 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
other: LOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section 8.4.3.1. Tables R.8-3 and R.8-4, pages 30-32.
Justification:
None required, DNEL is based on a NOAEL.
AF for differences in duration of exposure:
10
Justification:
Acute to chronic exposure (Expert judgement).
AF for interspecies differences (allometric scaling):
4
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section 8.4.3.1. Table R.8-3, page 30.
AF for intraspecies differences:
5
Justification:
As per E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Appendix, R.8-3, Table 8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
E.C.H.A. Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of the dose [concentration]-response for human health, Section R.8.4.3.1. page 36-37.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

The DENELs for the Generally Population were generally derived to protect for the corrosive/irritating and skin sensitising effects of the substance, Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol.