Blue MGi 1037-Na (notification presscake)

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.82 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

Dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

61.7 mg/m³

Explanation for the modification of the dose descriptor starting point:

Please refer to "Additional information worker" for details.

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable, therefore no additional factor is applied.

AF for differences in duration of exposure:

6

Justification:

Default factor for extrapolation from sub-acute to chronic is applied.

AF for interspecies differences (allometric scaling):

1

Justification:

No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

AF for intraspecies differences:

5

Justification:

The default value for the relatively homogenous group "worker" is used.

AF for the quality of the whole database:

1

Justification:

The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties:

1

Justification:

Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.33 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):

300

Dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

700 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Please refer to "Additional information worker" for details.

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:

Default factor for extrapolation from sub-acute to chronic is applied.

AF for interspecies differences (allometric scaling):

4

Justification:

The default allometric scaling factor for the differences between rats and humans is applied.

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

AF for intraspecies differences:

5

Justification:

The default value for the relatively homogenous group "worker" is used.

AF for the quality of the whole database:

1

Justification:

The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties:

1

Justification:

Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - workers

General

DNEL derivation for the test item is performed under consideration of the recommendations of ECHA, Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose-response for human health (Version: 2.1, November 2012).

Inhalation

Long term, systemic DNEL – exposure via inhalation (workers)

Using a conservative approach, a worker DNEL (long-term inhalation exposure) is calculated. This worker long-term DNEL is considered to ensure also an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).

 

No repeated dose toxicity study with the test item is available. However, a sub-acute toxicity study with a read-across substance is available and considered suitable. For more details on read-across justification please refer to respective IUDLID Section. Based on an OECD TG 407 study with the read-across substance, daily oral administration to rats revealed signs of toxicity in the high and mid dose tested i. e. 200 and 1000 mg/kg bw/d, respectively. The NOAEL for systemic toxicity was therefore considered to be 50 mg/kg bw/day. This NOAEL of systemic toxicity is applied as Point of Departure for DNEL derivation since it is considered to reflect worst case assumption.

 

Step 1: PoD: NOAEL = 50 mg/kg bw/day

Step 2: Modification of PoD:

Standard respiratory volume, human (sRVhuman) for 8 h per person (70 kg): 6.7 m³

Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw

Worker respiratory volume (wRV) for 8 hours with light physical activity per person: 10 m³

 

Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50%/100 % (default)

Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker

 

Corrected NOAEC (inhalation) for workers:

= 50 mg/kg bw/day x 0.5x1/0.38 m³/kg bw/day x (6.7 m3/10 m³) x 1.4

= 61.7 mg/m³

 

Step 3: Overall AF= 75

 

Dose response relationship AF: 1
The dose response relationship is considered unremarkable, therefore no additional factor is applied.

 

Exposure duration AF: 6
Default factor for extrapolation from sub-acute to chronic is applied.

 

Intraspecies AF (worker): 5
The default value for the relatively homogenous group "worker" is used.

 

Interspecies AF, remaining differences: 2.5
The recommended AF for other interspecies differences is applied.

 

Allometric scaling AF: 1
No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).

 

Whole database AF: 1
The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

 

AF for remaining uncertainties: 1
Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

 

In conclusion, long term systemic inhalation DNEL, workers = 0.82 mg/m³

 

Acute, systemic DNEL- exposure via inhalation (workers)

There is no short-term or long-term toxicity study via inhalation route available for the test item. Due to its very low vapour pressure (< 1 Pa), high peak-inhalation exposure via vapors is not considered as relevant. However, the substance is a powder and exposure to dust might occur. The potential for adsorption directly across the respiratory tract epithelium is negligible based on the very low Pow and high molecular weight of the substance. Thus, the acute inhalation DNEL was not derived. The long-term DNELs are considered sufficient to ensure that acute effects do not occur. In addition, the test item is not classified as acutely toxic via inhalation or dermal route.

Long term & acute, local DNEL- exposure via inhalation (workers)

The substance is classified for eye damage (Cat.1) and in conclusion local mucosal membrane damage of the respiratory membranes might be possible. The potential for adsorption directly across the respiratory tract epithelium is negligible based on the very low Pow and high molecular weight of the substance. In order to guarantee adequately control of risks, it is necessary to stipulate risk management measures that prevent eye and mucous membrane exposure.

Dermal

Long term, systemic DNEL- exposure via dermal route (workers)

No repeated dose dermal toxicity study with the test item is available. Therefore, long-term dermal DNEL was derived by route-to-route extrapolation.

The NOAEL of 50 mg/kg bw/day derived from a sub-chronic toxicity study performed with a structural analogue substance was used as the Point of Departure.

 

Step 1: PoD: NOAEL = 50 mg/kg bw/day

Step 2: Modification into a correct starting point:

 

Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker.

Oral absorption of the rat/ dermal absorption of humans (ABS oral-rat / ABS derm-human): 100%/10 %

A low dermal absorption value can be expected due to the physico- chemical properties of the test item. The oral absorption is estimated to 100%, and the dermal absorption is estimated to 10%.

Corrected NOAEL (dermal) for workers

= 50 mg/kg bw/day x 10 x 1.4

= 700 mg/kg bw/day

 

Step 3:Overall AF= 300

Dose-response relationship AF: 1

The dose response relationship is considered unremarkable. Therefore, no additional factor is used.

Exposureduration AF: 6
Default factor for extrapolation from sub-acute to chronic is applied.

Interspecies AF, allometric scaling (rat to human): 4

The default allometric scaling factor for the differences between rats and humans is applied.

Interspecies AF, remaining differences: 2.5

The recommended AF for other interspecies differences is applied.

Intraspecies AF (worker): 5

The default value for the relatively homogenous group "worker" is used

 

Whole database AF: 1
The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

 

AF for remaining uncertainties: 1
Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

 

In conclusion, long term systemic dermal DNEL, workers = 2.33 mg/kg bw/day

 

Acute, systemic DNEL- dermal exposure (workers)

An acute dermal toxicity study is available for the test item. Based on the results the test item is not classified for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP). Thus, the acute systemic dermal DNEL was not derived. Further, long-term DNELs are considered sufficient to ensure that acute effects do not occur.

Long term & acute, local DNEL- dermal exposure (workers)

The test substance is not classified for skin irritation/corrosion or skin sensitization. Therefore, no hazard was identified. 

Hazard to the eye-local effects (worker)

The test item is classified for eye damage Cat 1 (H318:”Causes serious eye damage”) under Regulation (EC) No 1272/2008, as amended for the twelth time in Regulation (EU) No 2018/551.Thus, a qualitative risk assessment is done and the substance is assigned to the medium hazard band in accordance with ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (2016).

 References

ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8:

Characterisation of dose [concentration]-response for human health. Version 2.1, November 2012

ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.14 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

Dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

21.7 mg/m³

Explanation for the modification of the dose descriptor starting point:

Please refer to "Additional information general population" for details.

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:

Default factor for extrapolation from sub-acute to chronic is applied.

AF for interspecies differences (allometric scaling):

1

Justification:

No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

AF for intraspecies differences:

10

Justification:

The default value for the relatively heterogeneous group "general population" is used.

AF for the quality of the whole database:

1

Justification:

The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties:

1

Justification:

Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.83 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

Dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

500 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Please refer to "Additional information general population" for details.

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:

Default factor for extrapolation from sub-acute to chronic is applied.

AF for interspecies differences (allometric scaling):

4

Justification:

The default allometric scaling factor for the differences between rats and humans is applied.

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

AF for intraspecies differences:

10

Justification:

The default value for the relatively heterogeneous group "general population" is applied.

AF for the quality of the whole database:

1

Justification:

The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties:

1

Justification:

Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

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:

0.083 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

Dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

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:

Default factor for extrapolation from sub-acute to chronic is applied.

AF for interspecies differences (allometric scaling):

4

Justification:

The default allometric scaling factor for the differences between rats and humans is applied.

AF for other interspecies differences:

2.5

Justification:

The recommended AF for other interspecies differences is applied.

AF for intraspecies differences:

10

Justification:

The default value for the relatively heterogeneous group "general population" is used.

AF for the quality of the whole database:

1

Justification:

The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties:

1

Justification:

Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - General Population

Inhalation

Long term, systemic DNEL – exposure by inhalation (general population)

Using a conservative approach, a DNEL for general population (long-term inhalation exposure) is calculated. This long-term DNEL is considered to ensure also an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).

 

No repeated dose toxicity study with the test item is available. However, a sub-acute toxicity study with a read-across substance is available and considered suitable. For more details on read-across justification please refer to respective IUDLID Section. Based on an OECD TG 407 study with the read-across substance, daily oral administration to rats revealed signs of toxicity in the high and mid dose tested i. e. 200 and 1000 mg/kg bw/d, respectively. The NOAEL for systemic toxicity was therefore considered to be 50 mg/kg bw/day. This NOAEL of systemic toxicity is applied as Point of Departure for DNEL derivation since it is considered to reflect worst case assumption.

 

Step 1: PoD: NOAEL = 50 mg/kg bw/day

Step 2: Modification of PoD:

Standard respiratory volume of the rat (sRVrat) for 24 hours: 1.15 m3/kg bw

 

Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50%/100 % (default)

 

Corrected NOAEC (inhalation) for general population:

= 50 mg/kg bw/day x 1/1.15 m3/kg bw/day x0.5

= 21.7 mg/m³

 

Step 3: Overall AF= 150

Dose response relationship AF: 1
The dose response relationship is considered unremarkable, therefore no additional factor is used.

Exposureduration AF: 6
Default factor for extrapolation from sub-acute to chronic is applied.

Intraspecies AF (General population): 10
The default value for the relatively heterogeneous group "general population" is used.

Interspecies AF, remaining differences: 2.5
The recommended AF for other interspecies differences is applied.

Allometric scaling AF: 1
No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).

Whole database AF: 1
The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties: 1
Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

 

In conclusion, long term systemic inhalation DNEL, general population = 0.14 mg/m³

 

Acute, systemic DNEL- exposure via inhalation (general population)

There is no short-term or long-term toxicity study via inhalation route available for the test item. Due to its very low vapour pressure (< 1 Pa), high peak-inhalation exposure via vapors is not considered as relevant. The potential for adsorption directly across the respiratory tract epithelium is negligible based on the very low Pow and high molecular weight of the substance. Thus, the acute inhalation DNEL was not derived. The long-term DNELs are considered sufficient to ensure that acute effects do not occur. In addition, the test item is not classified as acutely toxic via inhalation or dermal route.

Long-term and short-term, local DNEL- exposure via inhalation (general population)

The substance is classified for eye damage (Cat.1) and in conclusion local mucosal membrane damage of the respiratory membranes might be possible. The substance is only used included in liquids for consumer products and the vapour pressure is very low. Therefore, exposure via dust or vapour inhalation is not considered as relevant and local respiratory irritation is expected to be low. As a result, a low hazard is derived. In order to guarantee "adequately control of risks", it is necessary to stipulate risk management measures that prevent mucous membrane exposure.

 

Dermal

Long term, systemic DNEL- exposure via dermal route (general population)

 

No repeated dose dermal toxicity study with the test item is available.

 

Step 1: PoD: NOAEL= 50 mg/kg bw/day

Step 2: Modification into a correct starting point:
Correction for difference between human and experimental exposure conditions: 7 d rat, 24 h/7 d, 24h general population = 1

 

Oral absorption of the rat/ dermal absorption of humans (ABS oral-rat / ABS derm-human): 100%/10 %

A low dermal absorption value can be expected due to the physico- chemical properties of the test item.

 

Corrected NOAEL (dermal) for general population:

= 50 mg/kg bw/day x 10

= 500 mg/kg bw/day

 

Step 3: Overall AF= 600

Dose-response relationship AF: 1
The dose response relationship is considered unremarkable, therefore no additional factor is used.

Exposureduration AF: 6
Default factor for extrapolation from sub-acute to chronic is applied.

Interspecies AF, allometric scaling (rat to human): 4
The default allometric scaling factor for the differences between rats and humans is applied.

Interspecies AF, remaining differences: 2.5
The recommended AF for other interspecies differences is applied.

Intraspecies AF (general population): 10
The default value for the relatively heterogeneous group "general population" is applied

Whole database AF: 1
The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties: 1
Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

In conclusion,long term systemic dermal DNEL, general population = 0.83 mg/kg bw/day

Acute, systemic DNEL- dermal exposure (general population)

An acute dermal toxicity study is available for the test item. Based on the results the test item is not classified for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP). Thus, the acute systemic dermal DNEL was not derived. Further, long-term DNELs are considered sufficient to ensure that acute effects do not occur.

Long term & acute, local DNEL- dermal exposure (general population)

The test substance is not classified for skin irritation/corrosion or skin sensitization. Therefore, no hazard was identified. 

Long term, systemic DNEL- exposure by oral route (general population)

Based on an OECD TG 407 study with the read-across substance, daily oral administration to rats revealed signs of toxicity in the high and mid dose tested i. e. 200 and 1000 mg/kg bw/d, respectively. The NOAEL for systemic toxicity was therefore considered to be 50 mg/kg bw/day. This NOAEL of systemic toxicity is applied as Point of Departure for DNEL derivation since it is considered to reflect worst case assumption.

 

Step 1: PoD: NOAEL = 50 mg/kg bw/day

Step 2: Overall AF= 600

Dose-response relationship AF: 1
The dose response relationship is considered unremarkable, therefore no additional factor is used.

Exposureduration AF: 6
Default factor for extrapolation from sub-acute to chronic is applied.

Interspecies AF, allometric scaling (rat to human): 4
The default allometric scaling factor for the differences between rats and humans is applied.

Interspecies AF, remaining differences: 2.5
The recommended AF for other interspecies differences is applied.

 

Intraspecies AF (general population): 10
The default value for the relatively heterogeneous group "general population" is used.

Whole database AF: 1
The applied study is considered as reliable study with a Klimisch code 1. Therefore no additional AF is applied.

AF for remaining uncertainties: 1
Even though the Point of departure for DNEL Derivation origins from a structural analogue substances, the read-across approach is considered unremarkable and DNEL derivation is considered conservative. Thus, there are no remaining uncertainties on this approach.

In conclusion, long term systemic oral DNEL, general population= 0.083 mg/kg bw/day

 

Acute, systemic DNEL- exposure by oral route (general population)

According to ECHA Guidance on information requirements and chemical safety, Chapter R.8, Appendix R. 8-8, "a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified. The substance has low acute oral toxicity with the LD50 >2000 mg/kg bw. Therefore, a DNEL is not required.

 

Hazard to the eye-local effects (general population)

The test item is classified for eye damage Cat 1 (H318:”Causes serious eye damage”) under Regulation (EC) No 1272/2008, as amended for the twelth time in Regulation (EU) No 2018/551.Thus, a qualitative risk assessment is done and the substance is assigned to the medium hazard band in accordance with ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (2016).

 

References

ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8:

Characterization of dose [concentration]-response for human health. Version 2.1, November 2012

ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterization, Version 3.0, May 2016