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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.529 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):
25
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13.22 mg/m³
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint is for oral exposure and there are no long term toxicity data available via the inhalation route.

The dose descriptor staring point was derived from the most sensitive toxicity endpoint which is the 28-day repeat oral toxicity NOAEL of 15 mg/kg/day. According to Table 2 of ECHA practical guide 14,

For workers inhalation NOAEC:

Inhalatory NOAEC= oral NOAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)=15mg/kg/d *(1/0.38 m3/kg/d)*0.67*0.5/1=13.22 mg/m3

AF for dose response relationship:
1
Justification:
default factor for starting point for DNEL derivation NOAEL
AF for differences in duration of exposure:
2
Justification:
although the study is a 28-day study, use of an AF for 90-day study is considered appropriate as it is considered that the repeat dose toxicity of MPP is sufficiently characterized in the available data and that subchronic toxicity testing would be unlikely to provide further relevant information.
AF for interspecies differences (allometric scaling):
1
Justification:
not needed for inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value
AF for the quality of the whole database:
1
Justification:
the key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
AF for remaining uncertainties:
1
Justification:
no other uncertainties
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:
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):
100
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint is for oral exposure and there are no long term toxicity data available via the dermal route.

The dose descriptor staring point was derived from the most sensitive toxicity endpoint which is the 28-day repeat oral toxicity NOAEL of 15 mg/kg/day. According to Table 2 of ECHA practical guide 14, NOAEL oral =NOAEL dermal x (absorption oral/absorption dermal). In the absence of any data it is assumed that 100% absorption occurs for both oral and dermal routes and therefore NOAEL oral = NOAEL dermal = 15mg/kg/day.  

AF for dose response relationship:
1
Justification:
default factor for starting point for DNEL derivation NOAEL
AF for differences in duration of exposure:
2
Justification:
although the study is a 28-day study, use of an AF for 90-day study is considered appropriate as it is considered that the repeat dose toxicity of MPP is sufficiently characterized in the available data and that subchronic toxicity testing would be unlikely to provide further relevant information.
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value
AF for the quality of the whole database:
1
Justification:
the key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
AF for remaining uncertainties:
1
Justification:
no other uncertainties
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
0.13 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):
50
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
6.52 mg/m³
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint is for oral exposure and there are no long term toxicity data available via the inhalation route.

The dose descriptor staring point was derived from the most sensitive toxicity endpoint which is the 28-day repeat oral toxicity NOAEL of 15 mg/kg/day. According to Table 2 of ECHA practical guide 14,

For general population inhalation NOAEC:

Inhalatory NOAECcorr=NOAELoral*(1/1.15 m3/kg/d)*(ABSoral-rat/ABSinh-human) = 15 mg/kg/d*(1/1.15 m3/kg/d)*(0.5/1)=6.52 mg/m3

AF for dose response relationship:
1
Justification:
default factor for starting point for DNEL derivation NOAEL
AF for differences in duration of exposure:
2
Justification:
although the study is a 28-day study, use of an AF for 90-day study is considered appropriate as it is considered that the repeat dose toxicity of MPP is sufficiently characterized in the available data and that subchronic toxicity testing would be unlikely to provide further relevant information.
AF for interspecies differences (allometric scaling):
1
Justification:
not needed for inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
the key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
AF for remaining uncertainties:
1
Justification:
no other uncertainties
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:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.075 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):
200
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Most sensitive endpoint is for oral exposure and there are no long term toxicity data available via the dermal route.

The dose descriptor starting point was derived from the most sensitive toxicity endpoint which is the 28-day repeat oral toxicity NOAEL of 15 mg/kg/day. According to Table 2 of ECHA practical guide 14, NOAEL oral =NOAEL dermal x (absorption oral/absorption dermal). In the absence of any data it is assumed that 100% absorption occurs for both oral and dermal routes and therefore NOAEL oral = NOAEL dermal = 15mg/kg/day.  

AF for dose response relationship:
1
Justification:
default factor for starting point for DNEL derivation NOAEL
AF for differences in duration of exposure:
2
Justification:
although the study is a 28-day study, use of an AF for 90-day study is considered appropriate as it is considered that the repeat dose toxicity of MPP is sufficiently characterized in the available data and that subchronic toxicity testing would be unlikely to provide further relevant information.
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
The key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
AF for remaining uncertainties:
1
Justification:
No other uncertainties
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.075 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):
200
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

not applicable - route to route extrapolation is not required

AF for dose response relationship:
1
Justification:
Default factor for starting point for DNEL derivation NOAEL
AF for differences in duration of exposure:
2
Justification:
although the study is a 28-day study, use of an AF for 90-day study is considered appropriate as it is considered that the repeat dose toxicity of MPP is sufficiently characterized in the available data and that subchronic toxicity testing would be unlikely to provide further relevant information.
AF for interspecies differences (allometric scaling):
4
Justification:
allometeric scaling factor for the rat
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
The key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population