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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27.6 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):
11
Dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
304.01 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 605*(6 h/ 8 h) *(6.7 m3/10 m3) = 304.01 mg/m3.

AF for dose response relationship:
1
Justification:
Default, NOAEC
AF for differences in duration of exposure:
2
Justification:
Default, subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default, inhalation rat to inhalation human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
2.2
Justification:
Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
AF for the quality of the whole database:
1
Justification:
Default, guideline study
AF for remaining uncertainties:
1
Justification:
Default, no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
73.6 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):
5.5
DNEL extrapolated from long term DNEL

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:
DNEL (Derived No Effect Level)
Value:
0.91 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):
44
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No correction was made to the dose descriptor starting point.

AF for dose response relationship:
1
Justification:
Default, NOAEL
AF for differences in duration of exposure:
2
Justification:
Default, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default, oral rat to dermal human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
2.2
Justification:
Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
AF for the quality of the whole database:
1
Justification:
Default, guideline study
AF for remaining uncertainties:
1
Justification:
Default, no remaining uncertainties
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:
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:
DNEL (Derived No Effect Level)
Value:
6.8 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):
16
Dose descriptor starting point:
NOAEC
Value:
605 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
108 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhalation): Correction for exposure duration (6 h/d to 24 h/d), correction for dosing frequency: 5 d/wk to 7 d/wk. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 605 * (6/24) * (5/7) = 108.0 mg/m³.

AF for dose response relationship:
1
Justification:
Default, NOAEC
AF for differences in duration of exposure:
2
Justification:
Default, subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default, inhalation rat to inhalation human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
AF for the quality of the whole database:
1
Justification:
Default, guideline study
AF for remaining uncertainties:
1
Justification:
Default, no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
54.4 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):
8
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.63 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):
64
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No correction was made to the dose descriptor starting point.

AF for dose response relationship:
1
Justification:
Default, NOAEL
AF for differences in duration of exposure:
2
Justification:
Default, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default, oral rat to dermal human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
AF for the quality of the whole database:
1
Justification:
Default, guideline study
AF for remaining uncertainties:
1
Justification:
Default, no remaining uncertainties
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:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.63 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):
64
Dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No correction was applied to the dose descriptor starting point.

AF for dose response relationship:
1
Justification:
Default, NOAEL
AF for differences in duration of exposure:
2
Justification:
Default, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default, oral rat to oral human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
3.2
Justification:
Substance-specific intraspecies assessment factor (see Section 7.1 Toxicokinetics)
AF for the quality of the whole database:
1
Justification:
Default, guideline study
AF for remaining uncertainties:
1
Justification:
Default, no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

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