Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.35 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL/NOAEC
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.66 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL/NOAEC
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
0.58 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
86.96 mg/m³
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion. The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL/NOAEC
AF for differences in duration of exposure:
6
Justification:
ubacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health and ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14. Details are given in the discussion.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL/NOAEC
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL/NOAEC
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic. DNEL is based on a (oral) OECD 422 (28 d) (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population