mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.474 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):

12.5

Dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

5.92 mg/m³

Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable.

AF for differences in duration of exposure:

1

Justification:

No further extrapolation factor is needed since a chronic study is already used as starting point.

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 interspecies differences is used.

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 quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

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:

9.6 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):

50

Dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

480 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

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

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable.

AF for differences in duration of exposure:

1

Justification:

No further extrapolation factor is needed since a chronic study was already used as starting point.

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 interspecies differences is used.

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 quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

high 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

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

Based on an OECD TG 453 study with daily dietary administration of the test item at concentration levels of 0, 20, 60, 125 or 750 ppm to Crl: CD BR rats for a period of 52 weeks, a NOAEL for systemic toxicity and carcinogenicity of 125 ppm (4.8 mg/kg bw/d in males and 6.7 mg/kg bw/d in females) was determined. Therefore, the NOAEL of 4.8 mg/kg bw/d is applied as Point of Departure for DNEL derivation.

Step 1: Point of Departure (PoD): NOAEL = 4.8 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): 1/2 (default)

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

Corrected NOAEC (inhalation) for workers:

= 4.8 mg/kg bw/day x 0.5 x 1/0.38 m3/kg bw/day x (6.7 m3/10 m3) x 1.4

= 5.92 mg/m3

Step 3: Overall AF= 12.5

Dose response relationship AF: 1

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

Exposure duration AF: 1

No further extrapolation factor is needed since a chronic study was already used as starting point.

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).

Interspecies AF, other 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 quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties: 1
DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

In conclusion,long term systemic inhalation DNEL, workers = 0.474 mg/m3

 

Acute, systemic DNEL- exposure via inhalation (workers)

The test item is not considered to become available as vapour due to its very low vapour pressure (< 1 Pa).

In a study conducted according to OECD Guideline 403 with Wistar rats, the effects of the test item exposed as aerosol were investigated. The maximum achievable aerosol concentration of the test item was administered for 4 hours (head exposure only). The test substance aerosol was directed into the animals’ noses. As no mortality occurred, the LC50 value was determined to be greater than the maximum achievable aerosol concentration.

Thus, the acute inhalation DNEL was not derived. Furthermore, 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 the oral, dermal or inhalation route.

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

In the acute inhalation toxicity study according to OECD Guideline 403, signs of nasal irritation during the 4 hours exposure period were observed. However, slight signs of irritation in the nasal cavity are in general regarded as unspecific findings commonly observed with high aerosol concentrations. The slight to moderate treatment related vascular lesions in the lungs, liver and kidney observed in the treated animals are considered a systemic effect. Based on the absence of mortality during the study, the test substance is not classified for acute systemic toxicity. It is also not classified for skin and eye irritation according to Regulation (EC) No 1272/2008, hence not indicating local mucosal membrane damage. Therefore, no DNEL is required.

Dermal

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

There are no relevant experimental data on repeated dermal exposure. Therefore, long-term dermal DNEL was derived by route-to-route extrapolation.

The NOAEL of 4.8 mg/kg bw/day derived from an OECD TG 453 study performed with the test item was used as the Point of Departure.

Step 1: PoD: NOAEL = 4.8 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.

Based on studies evaluating the absorption, a dermal absorption rate of 0.7 % and an oral absorption rate of 50 % have been identified. Therefore, the factor 50/0.7 has to be applied for modification into the correct starting point.

Dermal absorption 0.7 %, oral absorption 50 %

Corrected NOAEL (dermal) for workers:

= 4.8 mg/kg bw/day x 1.4 x 50/0.7

= 480 mg/kg bw/day

Step 3: Overall AF= 50

Dose response relationship AF: 1

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

Exposure duration AF: 1

No further extrapolation factor is needed since a chronic study was already used as starting point.

Allometric scaling AF: 4

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

Interspecies AF, other 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 quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties: 1
DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

In conclusion, long term systemic dermal DNEL, workers = 9.6 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 classified for skin sensitization, Cat 1. Therefore, appropriate qualitative risk managements measures should be implemented to avoid exposure. Thus, a qualitative risk assessment is applied and the substance is assigned to the high hazard band in accordance with ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (2016).

Hazard to the eye-local effects (worker)

The test item is not classified for eye irritation according to Regulation (EC) No 1272/2008 (CLP). Thus, no qualitative risk assessment is required.

 

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:

83.5 µg/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):

25

Dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

2.09 mg/m³

Explanation for the modification of the dose descriptor starting point:

Using a conservative approach, a general population DNEL (long-term inhalation exposure) is calculated. No repeated dose inhalation toxicity study with the test item is available. Therefore, the long-term inhalation DNEL was derived by route-to-route extrapolation from a chronic oral repeated dose toxicity study.

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable.

AF for differences in duration of exposure:

1

Justification:

No further extrapolation factor is needed since a chronic study was already used as starting point.

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 interspecies differences is used.

AF for intraspecies differences:

10

Justification:

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

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.43 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):

100

Dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

342.86 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated dermal exposure. Therefore, long-term dermal DNEL was derived by route-to-route extrapolation.

 

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable.

AF for differences in duration of exposure:

1

Justification:

No further extrapolation factor is needed since a chronic study was already used as starting point.

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 interspecies differences is used.

AF for intraspecies differences:

10

Justification:

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

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

high 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:

48 µg/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):

100

Dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

4.8 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No route-to-route-extrapolation necessary.

AF for dose response relationship:

1

Justification:

The dose response relationship is considered unremarkable.

AF for differences in duration of exposure:

1

Justification:

No further extrapolation factor is needed since a chronic study was already used as starting point.

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 interspecies differences is used.

AF for intraspecies differences:

10

Justification:

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

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

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

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 (general population)

Using a conservative approach, a general population DNEL (long-term inhalation exposure) is calculated. No repeated dose inhalation toxicity study with the test item is available. Therefore, the long-term inhalation DNEL was derived by route-to-route extrapolation from an oral repeated dose toxicity study:

Based on an OECD TG 453 study with daily dietary administration of the test item at concentration levels of 0, 20, 60, 125 or 750 ppm to Crl: CD BR rats for a period of 52 weeks, a NOAEL for systemic toxicity and carcinogenicity of 125 ppm (4.8 mg/kg bw/d in males and 6.7 mg/kg bw/d in females) was determined. Therefore, the NOAEL of 4.8 mg/kg bw/d is applied as Point of Departure for DNEL derivation.

Step 1: Point of Departure (PoD): NOAEL = 4.8 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): 1/2 (default)

Corrected NOAEC (inhalation) for general population:

= 4.8 mg/kg bw/day x 1/1.15 x 0.5 m3/kg bw/day

= 2.087 mg/m3

Step 3: Overall AF= 25

Dose response relationship AF: 1

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

Exposure duration AF: 1

No further extrapolation factor is needed since a chronic study was already used as starting point.

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).

Interspecies AF, other differences: 2.5

The recommended AF for other interspecies differences is applied.

Intraspecies AF (general population): 10

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

Whole database AF: 1

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties: 1
DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

In conclusion,long term systemic inhalation DNEL, general populations = 0.0835 mg/m3

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

The test item is not considered to become available as vapour due to its very low vapour pressure (< 1 Pa).

In a study conducted according to OECD Guideline 403 with Wistar rats, the effects of the test item exposed as aerosol were investigated. The maximum achievable aerosol concentration of the test item was administered for 4 hours (head exposure only). The test substance aerosol was directed into the animals’ noses. As no mortality occurred, the LC50 value was determined to be greater than the maximum achievable aerosol concentration.

Thus, the acute inhalation DNEL was not derived. Furthermore, 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 the oral, dermal or inhalation route.

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

In the acute inhalation toxicity study according to OECD Guideline 403, signs of nasal irritation during the 4 hours exposure period were observed. However, slight signs of irritation in the nasal cavity are in general regarded as unspecific findings commonly observed with high aerosol concentrations.The slight to moderate treatment related vascular lesions in the lungs, liver and kidney observed in the treated animals are considered a systemic effect. Based on the absence of mortality during the study, the test substance is not classified for acute systemic toxicity. It is also not classified for skin and eye irritation according to Regulation (EC) No 1272/2008, hence not indicating local mucosal membrane damage. Therefore, no DNEL is required. 

Dermal

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

There are no relevant experimental data on repeated dermal exposure. Therefore, long-term dermal DNEL was derived by route-to-route extrapolation.

The NOAEL of 4.8 mg/kg bw/day derived from an OECD TG 453 study performed with the test item was used as the Point of Departure.

Step 1: PoD: NOAEL = 4.8 mg/kg bw/day

Step 2: Modification into a correct starting point:

Based on studies evaluating the absorption, a dermal absorption rate of 0.7 % and an oral absorption rate of 50 % have been identified. Therefore, the factor 50/0.7 has to be applied for modification into the correct starting point.

Corrected NOAEL (dermal) for general populations:

= 4.8 mg/kg bw/day x 50/0.7

= 342.86  mg/kg bw/day

Step 3: Overall AF= 100

Dose response relationship AF: 1

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

Exposure duration AF: 1

No further extrapolation factor is needed since a chronic study was already used as starting point.

Allometric scaling AF: 4

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

Interspecies AF, other differences: 2.5

The recommended AF for other interspecies differences is applied.

Intraspecies AF (general population): 10

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

Whole database AF: 1

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties: 1
DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

In conclusion, long term systemic dermal DNEL, general populations = 3.43 mg/kg bw/day

Acute, systemic DNEL- dermal exposure (general populations)

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. Furthermore, long-term DNELs are considered sufficient to ensure that acute effects do not occur.

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

The test substance is classified for skin sensitization, Cat 1 according to Regulation (EC) No 1272/2008 (CLP). Therefore, appropriate qualitative risk managements measures should be implemented to avoid exposure. Thus, a qualitative risk assessment is applied and the substance is assigned to the high hazard band in accordance with ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (2016).

 

Oral route

Long term, systemic DNEL – exposure via oral route (general population)

Using a conservative approach, a general population DNEL (long-term inhalation exposure) is calculated. Based on an OECD TG 453 study with daily dietary administration of the test item at concentration levels of 0, 20, 60, 125 or 750 ppm to Crl: CD BR rats for a period of 52 weeks, a NOAEL for systemic toxicity and carcinogenicity of 125 ppm (4.8 mg/kg bw/d in males and 6.7 mg/kg bw/d in females) was determined. Therefore, the NOAEL of 4.8 mg/kg bw/d is applied as Point of Departure for DNEL derivation.

 

Step 1: Point of Departure (PoD): NOAEL = 4.8 mg/kg bw/day

Step 2:

Overall AF= 100

Dose response relationship AF: 1

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

Exposure duration AF: 1

No further extrapolation factor is needed since a chronic study was already used as starting point.

Allometric scaling AF: 4

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

Interspecies AF, other differences: 2.5

The recommended AF for other interspecies differences is applied.

Intraspecies AF (general population): 10

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

Whole database AF: 1

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties: 1
DNEL Derivation is considered conservative, reflecting reasonable worst case assumptions. Therefore, no further AF for remaining uncertainties is applied.

In conclusion, long term systemic inhalation DNEL, general populations = 0.0048 mg/m3

Acute, systemic DNEL- exposure via oral route (general populations)

The test item is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP). Thus, no DNEL is required. Furthermore, long-term DNELs are considered sufficient to ensure that acute effects do not occur.

 

Hazard to the eye-local effects (general population)

The test item is not classified for eye irritation according to Regulation (EC) No 1272/2008 (CLP). Thus, no qualitative risk assessment is required.

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.