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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

1. Identification of relevant dose descriptor

For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 427 mg/kg/day.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Correction of dose descriptor

NOAEL (oral) is converted into a NOAEL(corrected)in accordance toGuidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.

Workers: NOAEL (oral) = 427 mg/kg bw =>NOAEL(corrected)= 753 mg/m3

4. Application of assessment factors

The following assessment factors were chosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation), remaining differences account for 2.5. Intraspecies differences account for a factor of 5. For exposure duration a factor of 2 is employed. Overall, assessment factors of 100 and 25 were employed for oral/dermal and inhalation route, respectively.

5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects

 

DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.

DNEL- acute, inhalation, local:

Not quantifiable.

DNEL- acute, dermal, systemic: The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided.

DNEL- acute, dermal, local:

Not quantifiable

DNEL- long-term, inhalation, local:

Not quantifiable.

 DNEL- long-term, inhalation, systemic:

NOAEL (corrected) / Sum of assessment factors applicable

753 mg/m3 /25 = 30 mg/m3

DNEL- long-term, dermal, systemic:

NOAEL (oral) / Sum of assessment factors applicable

427 mg/kg bw / 100 = 4.3 mg/kg bw

The dermal route is typically covered by oral route information in the absence of data for this administration route.

DNEL- long-term, dermal, local:

Not quantifiable and not considered applicable.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

1. Identification of relevant dose descriptor

For the derivation of the DNELs, the 90-Day oral toxicity study in rats was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 427 mg/kg/day.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Correction of dose descriptor

NOAEL (oral) is converted into a NOAEL(corrected)in accordance toGuidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health, ECHA, May 2008.

General population: NOAEL (oral) = 427 mg/kg bw =>NOAEL(corrected)= 371 mg/m3

4. Application of assessment factors

The following assessment factors were chosen: A correction for differences in metabolic rate per body weight was made by an allometric scaling factor of 4 (except for inhalation), remaining differences account for 2.5. Intraspecies differences account for a factor of 5. For exposure duration a factor of 2 is employed. Overall, assessment factors of 200 and 50 were employed for oral/dermal and inhalation route, respectively.

5.Selection of the critical DNEL(s)/DMELs and/or qualitative/semi-quantitative descriptor for critical health effects

 

DNEL- acute, inhalation, systemic:The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure (especially for inhalation) can be avoided.

DNEL- acute, inhalation, local:

Not quantifiable.

DNEL- acute, dermal, systemic: The acute DNELs could not be calculated directly but the long-term DNELs are sufficient to ensure that acute effects do not occur, provided high-peak acute exposure can be avoided.

DNEL- acute, dermal, local:

Not quantifiable

DNEL- long-term, inhalation, local:

Not quantifiable.

 DNEL- long-term, inhalation, systemic:

NOAEL (corrected) / Sum of assessment factors applicable

371 mg/m3 /50 = 7.4 mg/m3

DNEL- long-term, dermal, systemic:

NOAEL (oral) / Sum of assessment factors applicable

427 mg/kg bw / 200 = 2.1 mg/kg bw

The dermal route is typically covered by oral route information in the absence of data for this administration route.

DNEL- long-term, dermal, local:

Not quantifiable and not considered applicable.

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