Propanoic acid, 2-(4-chloro-2-methylphenoxy)-, 2-ethylhexyl ester, (2R)-

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.34 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):

75

Dose descriptor starting point:

NOAEC

Value:

200 mg/m³

Modified dose descriptor starting point:

NOAEC

Explanation for the modification of the dose descriptor starting point:

A correction factor for the difference between human and experimental exposure conditions of 0.75 was included. Furthermore, the NOAEC was cprrected for the difference between respiratory rates under standard conditions and under conditions of light activity. See "Additional information".

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:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

1

Justification:

According to Table R.8.4 in chapter R.8 of the ECHA Guidance Document no AF is needed.

AF for other interspecies differences:

2.5

Justification:

The default value 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:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

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

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:

2.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

300

Dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

750 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

A correction factor for the difference between human and experimental exposure conditions of 0.75 was included. See "Additional information"

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:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

4

Justification:

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

AF for other interspecies differences:

2.5

Justification:

The default value 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:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

Route of original study:

Dermal

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

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).

Mecoprop-p-2 EHE is classified to be of moderate oral acute toxicity (Cat.4, LD50=1400 mg/kg bw), but is non-toxic after acute dermal exposure (LD50 > 2000 mg/kg bw). In an acute inhalation study the discriminating dose for Mecoprop-p-2EHE was in excess of 4.66 mg/L, which was the highest attainable concentration in this study. Mecoprop-p-2-EHE has a very low vapor pressure of 1.19E-4 at 20°C and therefore, vapor inhalation is an unlikely route of exposure. For assessing risk to humans, exposure to dust or liquid aerosol is of relevance. In vivo studies obtained no potential for skin and eye irritation/corrosion, but Mecoprop-p-2-EHE showed sensitizing properties in a LLNA. Therefore, the risk of sensitization after dermal exposure was assessed.

For repeated oral toxicity no study is available with Mecoprop-p-2-EHE, but with the structurally similar substance Mecoprop-P n-octyl ester. Here, the NOAEL in a subchronic feeding study according OECD TG 408 was 10.8 mg/kg bw/day. Systemic effects on kidney and liver were observed at higher dose levels. The NOAEL after repeated dermal application of Mecoprop-p-2EHE was above 1000 mg/kg bw/day for systemic and local effects, while no treatment-related gross lesions or microscopic findings were observed. This NOAEL was chosen as the point of departure for the determination of a long-term systemic DNEL for workers (dermal exposure).

In a 28 day repeated dose inhalation study male rats were exposed by nose-only inhalation for 6 hours, once daily, 5 days per week with 0 (air only), 0.02, 0.05 or 0.20 mg/L Mecoprop-p-2-EHE. Under the conditions of this study and based on the histopathology findings, the NOAEC was considered to be the high exposure level of 0.20 mg/L.This NOAEC was chosen as the point of departure for the determination of a long-term systemic DNEL for workers (exposure by inhalation).

For Mecoprop-p-2EHE no genotoxicity in vitro as well as in vivo was observed.

No study on toxicity on reproduction with the target substance Mecoprop-P 2-EHE is available. But a multi-generation study according OECD TG 416 with Mecoprop-P acid (MCPP-P acid), which is the main hydrolysis product of Mecoprop-P 2 -EHE in vivo is used for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ. Here, the NOAEL for toxicity on reproduction was 50 mg/kg bw/day in rats.

No study on teratogenicity with the target substance Mecoprop-P-2-EHE is available. But two OECD TG 414 studies with Mecoprop-P acid (MCPP-P acid) are used for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ. Here, the NOAEL for fetal toxicity was 50 mg/kg bw/day for rats and rabbits while no teratogenic effects were observed.

1.    Inhalation

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

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

Step 1: PoD

The NOAEC derived from an OECD TG 412 study with the target substance Mecoprop-P-2-EHE was used as the PoD.

Step 2: Modification into a correct starting point:  

Relevant dose descriptor (NOAEC): 200 mg/m3

inhalation absorption of the rat / inhalation absorption of humans (ABS inhal-rat / ABS inhal-human): 1

Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m3

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

Correction for difference between human and experimental exposure conditions: 6 h rat/8h worker

Corrected NOAEC (inhalation) for workers:

= 200 mg/m3 × 1 × (6.7 m3/10 m3) × 0.75

= 100.5 mg/m3

Step 3: Overall AF= 75

Intraspecies AF (worker): 5

Interspecies AF, remaining differences: 2.5

Dose response relationship AF: 1

Exposure duration AF (subacute to chronic): 6

In conclusion, long term systemic inhalation DNEL, workers = 1.34 mg/m3

Acute, systemic DNEL- exposure via inhalation (workers)

According to ECHA Guidance on information requirements and chemical safety, Chapter R.8, Appendix R. 8-8, „a DNEL for acute inhalation toxicity should be derived if an acute inhalation toxicity hazard (leading to C&L) has been identified. The substance has low acute inhalation toxicity with the LC50 of 4660 mg/kg. Therefore, a DNEL for acute/short term systemic exposure by inhalation was not determined.

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

As only slight irritating effects were observed in an acute inhalation study, which were reversible during the observation period and no distinct local effects after dermal application were observed, no DNELs for local effects, long and short term exposure by inhalation were determined.

2.    Dermal

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

Step 1: PoD and most sensitive endpoint: repeated dose dermal

The NOAEL derived from an OECD TG 410 study with Mecoprop-p-2EHE was used as the PoD.

Step 2: Modification into a correct starting point:

Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day

An in vivo toxicokinetic study with the target substance shows that oral absorption is very high. Consequently, a default factor of 1 is included for route-to-route extrapolation, which means that 100% absorption is assumed for oral absorption, and 100% for inhalation.

Correction for difference between human and experimental exposure conditions: 0.75

Corrected NOAEL (dermal) for workers:

= 1000 mg/kg bw/day× 0.75

= 750 mg/kg bw/day

Step 3: Overall AF= 300

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

Interspecies AF, remaining differences: 2.5

Interspecies AF, remaining differences: Interspecies differences are fully covered by the allometric

scaling

Intraspecies AF (worker): 5

Dose-response relationship AF: 1

Exposure duration AF (subacute to chronic): 6

In conclusion, long term systemic dermal DNEL, workers = 2.5 mg/kg bw/day

Acute, systemic DNEL- dermal exposure (workers)

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 dermal toxicity with the LD50 of >2000 mg/kg. Therefore, the DNEL is not required.

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

The substance is classified as skin sensitizer (Cat 1B, H317) in a respective study and based on the results a medium hazard is assumed for this endpoint (ECHA guidance Part E, Table E.3-1). Since the substance concentration in preparation is lower than 1% for professional use, local effects are not expected as no classification is required for this diluted mixtures (Regulation (EC) No 1272/2008 (CLP)).

Workers handling the neat substance or mixtures containing higher amounts of the substance shall use appropriate protection measures to avoid dermal exposure.

Hazard to the eye-local effects (worker)

The substance is not classified for eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

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:

0.24 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):

150

Dose descriptor starting point:

NOAEL

Value:

200 mg/m³

Modified dose descriptor starting point:

NOAEC

Value:

36 mg/m³

Explanation for the modification of the dose descriptor starting point:

A correction factor for the difference between human and experimental exposure conditions of 0.179 was included. See "Additional information".

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:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

1

Justification:

According to Table R.8.4 in chapter R.8 of the ECHA Guidance Document no AF is needed.

AF for other interspecies differences:

2.5

Justification:

The default value 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:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

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

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:

0.3 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

600

Dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Value:

179 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

A correction factor for the difference between human and experimental exposure conditions of 0.179 was included.

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:

The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

4

Justification:

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

AF for other interspecies differences:

2.5

Justification:

The default value 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:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

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

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

50 µg/kg bw/day

Most sensitive endpoint:

effect on fertility

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Dose descriptor starting point:

NOAEL

Value:

10 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:

2

Justification:

The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).

AF for interspecies differences (allometric scaling):

4

Justification:

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

AF for other interspecies differences:

2.5

Justification:

The default value 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. No repeated oral toxicity study with the target substance MCPP-P 2-EHE is available. But a multi-generation study according OECD TG 416 with MCCP-P acid, which is the main hydrolysis product of MCPP-P 2-EHE in vivo wasused for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ.

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.15 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):

0.33

DNEL extrapolated from long term DNEL

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).

Mecoprop-p-2 EHE is classified to be of moderate oral acute toxicity (Cat.4, LD50=1400 mg/kg bw), but is non-toxic after acute dermal exposure (LD50 > 2000 mg/kg bw). In an acute inhalation study the discriminating dose for Mecoprop-p-2EHE was in excess of 4.66 mg/L, which was the highest attainable concentration in this study. Mecoprop-p-2-EHE has a very low vapor pressure of 1.19E-4 at 20°C and therefore, vapor inhalation is an unlikely route of exposure. For assessing risk to humans, exposure to dust or liquid aerosol is of relevance. In vivo studies obtained no potential for skin and eye irritation/corrosion, but Mecoprop-p-2-EHE showed sensitizing properties in a LLNA. Therefore, the risk of sensitization after dermal exposure was assessed.

For repeated oral toxicity no study is available with Mecoprop-p-2-EHE, but with the structurally similar substance Mecoprop-P n-octyl ester. Here, the NOAEL in a subchronic feeding study according OECD TG 408 was 10.8 mg/kg bw/day. Systemic effects on kidney and liver were observed at higher dose levels. The NOAEL after repeated dermal application of Mecoprop-p-2EHE was above 1000 mg/kg bw/day for systemic and local effects, while no treatment-related gross lesions or microscopic findings were observed. This NOAEL was chosen as the point of departure for the determination of a long-term systemic DNEL (dermal exposure).

In a 28 day repeated dose inhalation study according OECD TG 412 male rats were exposed by nose-only inhalation for 6 hours, once daily, 5 days per week with 0 (air only), 0.02, 0.05 or 0.20 mg/L Mecoprop-p-2-EHE. Under the conditions of this study and based on the histopathology findings, the NOAEC was considered to be the high exposure level of 0.20 mg/L.This NOAEC was chosen as the point of departure for the determination of a long-term systemic DNEL (exposure by inhalation).

For Mecoprop-p-2EHE no genotoxicity in vitro as well as in vivo was observed.

No study on toxicity on reproduction with the target substance Mecoprop-P 2-EHE is available. But a multi-generation study according OECD TG 416 with Mecoprop-P acid (MCPP-P acid), which is the main hydrolysis product of Mecoprop-P 2 -EHE in vivo is used for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ. Here, the NOAEL for toxicity on reproduction was 50 mg/kg bw/day in rats.

No study on teratogenicity with the target substance Mecoprop-P-2-EHE is available. But two OECD TG 414 studies with Mecoprop-P acid (MCPP-P acid) are used for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ. Here, the NOAEL for fetal toxicity was 50 mg/kg bw/day for rats and rabbits while no teratogenic effects were observed.

 

1.    Inhalation

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

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

Step 1: PoD

The NOAEL derived from an OECD TG 412 study with the target substance Mecoprop-P-2-EHE was used as the PoD.

Step 2: Modification into a correct starting point:  

Relevant dose descriptor (NOAEC): 200 mg/m3

Inhalation absorption of the rat / inhalation absorption of humans (ABS inhal-rat / ABS inh-human): 1

Correction for difference between human and experimental exposure conditions: 6h/24hx5d/7d

Corrected NOAEC (inhalation) for general population:

= 200 mg/m3 x 1 x 0.179

= 36 mg/m3

Step 3:Overall AF= 150

Intraspecies AF (general population): 10

Interspecies AF, remaining differences: 2.5

Dose response relationship AF: 1

Exposure duration AF (subacute to chronic): 6

In conclusion,long term systemic inhalation DNEL, general population= 0.24 mg/m3

 Acute, systemic DNEL- exposure via inhalation (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 inhalation toxicity with the LC50 of 4660 mg/kg. Therefore, a DNEL for acute/short term systemic exposure by inhalation was not determined.

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

As only slight irritating effects were observed in an acute inhalation study, which were reversible during the observation period and no distinct local effects after dermal application were observed, no DNELs for local effects, long and short term exposure by inhalation were determined.

2.    Dermal

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

Step 1:PoD and most sensitive endpoint: repeated dose dermal

The NOAEL derived from an OECD TG 410 study with Mecoprop-p-2EHE was used as the PoD.

Step 2:Modification into a correct starting point:

Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day

An in vivo toxicokinetic study with the target substance shows that oral absorption is very high. Consequently, a default factor of 1 is included for route-to-route extrapolation, which means that 100% absorption is assumed for oral absorption, and 100% for inhalation.

Correction for difference between human and experimental exposure conditions: 0.179 (6h/24hx5 d/7d)

Corrected NOAEL (dermal):

= 1000 mg/kg bw/day× 0.179

= 179 mg/kg bw/day

Step 3:Overall AF= 600

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

Interspecies AF, remaining differences: 2.5

Interspecies AF, remaining differences: Interspecies differences are fully covered by the allometric

scaling

Intraspecies AF (general population): 10

Dose-response relationship AF: 1

Exposure duration AF (subacute to chronic): 6

In conclusion,long term systemic dermal DNEL, general population = 0.3 mg/kg bw/day

Acute, systemic DNEL- dermal exposure (general pupulation)

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 dermal toxicity with the LD50 of >2000 mg/kg. Therefore, the DNEL is not required.

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

The substance is classified as skin sensitizer (Cat 1B, H317) in a respective study and based on the results a medium hazard is assumed for this endpoint (ECHA guidance Part E, Table E.3-1). Since the substance concentration in preparation is lower than 1% for consumer use, local effects are not expected as no classification is required for this diluted mixtures (Regulation (EC) No 1272/2008 (CLP)).

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

Step 1: PoD

The NOAEL systemic derived from an OECD TG 416 study with the hydrolysis product Mecoprop-p was used as the PoD.

Step 2:Modification into a correct starting point:  

Relevant dose descriptor (NOAEL): 10 mg/kg bw/day

Step 3:Overall AF= 200

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

Interspecies AF, remaining differences: 2.5

Interspecies AF, remaining differences: Interspecies differences are fully covered by the allometric

scaling

Intraspecies AF (general population): 10

Dose-response relationship AF: 1

Exposure duration AF (subchronic to chronic): 2

In conclusion,long term systemic oral DNEL, general population= 50 µg/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 moderate acute oral toxicity with a LD50 of 1400 mg/kg bw. Therefore, a DNEL was extrapolated from the long term DNEL.

Hazard to the eye-local effects (general population)

The substance is not classified for eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

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