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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.79 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
other: NOAEL = 8 mg/kg bw/d
Modified dose descriptor starting point:
other: NOAEC = 19.75 mg/m3
Explanation for the modification of the dose descriptor starting point:

No repeated dose inhalation toxicity study is available. Therefore, the DNEL is derived on basis of a sub-chronic repeated oral toxicity study (reproductive toxicity) in the rat – two generation reproductive toxicity study, performed according to OECD 416 – oral exposure. Study performed on MCPA acid technical as the hydrolysis product of the MCPA-2EH ester.

It was concluded that NOAEL based on the above study is 100 ppm. This oral NOAEL for rats was re-calculated to mg/m3in the following way:

NOAEL = 100 ppm (concentration of MCPA acid in food, applied to exposed rats), which gives c.a. 100 mg of MCPA in 1 kg of food.

·        Taking into account average body weight and food intake, it gives NOAEL =                    8.0 mg/kg bw/day,

 

·        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:                1.4

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

 

Corrected NOAEC (inhalation) for workers = 8 [mg/kg bw/day] /  0.38 m³ [kg bw/day]) × (6.7 [m³]/10 [m³]) × 1.4  = 19.75 mg/m³

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):
1
Justification:
According to Table R.8.4 in chapter R.8 of the ECHA Guidance Document no AF is needed when route (oral)-to route (inhalation) is applied.
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:
No repeated inhalation toxicity study with the target substance MCPP-P 2-EHE is available. But a multi-generation study according OECD TG 416 with MCPA acid, which is the main hydrolysis product of MCPA-2EH in vivo was used for read-across. Both compounds have similar toxicological profiles with respect to dose level and target organ.
AF for remaining uncertainties:
1
Justification:
Conservative 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
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:
Oral
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.

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
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.047 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
other: NOAEL = 8 mg/kg bw/d
Modified dose descriptor starting point:
other: NOAEC = 2.33 mg/m3
Explanation for the modification of the dose descriptor starting point:

No repeated dose inhalation toxicity study is available. Therefore, the DNEL is derived on basis of a sub-chronic repeated oral toxicity study (reproductive toxicity) in the rat – two generation reproductive toxicity study, performed according to OECD 416 – oral exposure. Study performed on MCPA acid technical as the hydrolysis product of the MCPA-2EH ester.

It was concluded that NOAEL based on the above study is 100 ppm. This oral NOAEL for rats was re-calculated to mg/m3in the following way:

NOAEL = 100 ppm (concentration of MCPA acid in food, applied to exposed rats), which gives c.a. 100 mg of MCPA in 1 kg of food.

·        Taking into account average body weight and food intake, it gives NOAEL =                    8.0 mg/kgbw/day,

 

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

 

·        General population respiratory volume (wRV) for general population:                              20 m³ 

 

 

Corrected NOAEC (inhalation) for workers = 8 [mg/kgbw/day] /  1.15 m³ [kgbw/day]) × (6.7 [m³]/20 [m³]) =2.33 mg/m³

 

 

 

 

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):
1
Justification:
According to Table R.8.4 in chapter R.8 of the ECHA Guidance Document no AF is needed when route (oral)-to route (inhalation) is applied.
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 inhalation toxicity study with the target substance MCPA-2EH is available. But a multi-generation study according OECD TG 416 with MCPA acid, which is the main hydrolysis product of MCPA-2EH in vivo was used 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:
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
DNEL related information
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

DNEL was derived from NOAEL obtained in sub-chronic toxicity study in dermal exposure (OECD 410) performed on MCPA acid as the hydrolysis product of MCPA-2EH ester.

NOAEL is 1 000 mg/kg bw/d.

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

Overall assessment factor AF = 600 was also applied.

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:
5 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):
200
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

DNEL derived from NOAEL received from 90 days repeated toxicity study on dogs OECD 409

NOAEL < 1 mg/kg bw/d

Overal asessessment factor AF = 200 was applied.

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 MCPA-2EH is available. But a multi-generation study according OECD TG 409 with MCPA acid, which is the main hydrolysis product of MCPA-2EH in vivo was used 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:
0.3 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 000
Explanation for the modification of the dose descriptor starting point:

DNEL Derived from acute toxicity study, LD50 > 300 mg/kg. Overal assessment factor = 1000 was applied.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population