Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.2 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
Modified dose descriptor starting point:
NOAEC
Value:
26 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation study not warranted due to severe corrosive and sensitising effetcs.
AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
based on 28-day study
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
Default - pharmacodymanics
AF for intraspecies differences:
5
Justification:
Worker default
AF for the quality of the whole database:
1
Justification:
data are sufficient to reach conclusion
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 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
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance, there is no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by modifying the long-term systemic DNELs in a manner similar to estimating short-term exposure limits (STEL). This consists of applying a 3-fold multiplication factor to the long-term DNEL.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high 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 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):
75
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal studies are of limited use because of the severe corrosive and sensitising effects.
AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
based on 28-day study
AF for interspecies differences (allometric scaling):
1
Justification:
Skin
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Worker default
AF for the quality of the whole database:
1
Justification:
Data are sufficient to reach conclusion
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
75
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance, there is no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by modifying the long-term systemic DNELs in a manner similar to estimating short-term exposure limits (STEL). This consists of applying a 3-fold multiplication factor to the long-term DNEL.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Multiple studies show that the oral LD50 of MPCA in rats is >300 but <1000 mg/kg. The dermal LD50 in rabbits is >700 mg/kg (no deaths or signs of toxicity were observed). Testing for dermal toxicity at higher doses is not warranted as the material is corrosive to the skin. 

Observed local effects, particularly on the gastric mucosa following oral exposure, are probably attributable to direct chemical activity rather than to toxicity of the parent or metabolites.

The substance is severly corrosive and sensitising/ DNELs are developed for the purpose of quantitative CSA.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high 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:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

Multiple studies show that the oral LD50 of MPCA in rats is >300 but <1000 mg/kg. The dermal LD50 in rabbits is >700 mg/kg (no deaths or signs of toxicity were observed). Testing for dermal toxicity at higher doses is not warranted as the material is corrosive to the skin. 

Observed local effects, particularly on the gastric mucosa following oral exposure, are probably attributable to direct chemical activity rather than to toxicity of the parent or metabolites.

Severely corrosive substance. Contact with vapour will cause severe eye irritation. Contact with liquid may cause permanent eye damage. This endpoint will be assessed qualitatively.