Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 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):
10
Modified dose descriptor starting point:
NOAEC
Value:
6 mg/m³
Explanation for the modification of the dose descriptor starting point:
Correction of exposure duration in study (6 hrs/day, 5 days/week) to default worker exposure (8 hrs/day, 5 days/week); Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3).
AF for dose response relationship:
1
Justification:
default assessment factor
AF for differences in duration of exposure:
2
Justification:
extrapolation to chronic exposure based on a sub-chronic toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling is needed in case of inhalation exposure
AF for intraspecies differences:
5
Justification:
default assessment factor
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
toxicodynamic differences between humans and rats are not assumed; therefore the assessment factor for remaining differences is set to 1
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.96 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
default assessment factor
AF for differences in duration of exposure:
1
Justification:
the concentration and not the duration of exposure drive the appearance of the effect
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling is needed in case of inhalation exposure
AF for intraspecies differences:
5
Justification:
default assessment factor
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
2.5
Justification:
there could be significant quantitative differences in deposition, airflow patterns, clearance rates and protective mechanisms between humans and animals and since there is no data available to inform on this uncertainty; therfore, it is prudent to assume that humans would be more sensitive than animals to local effects on the respiratory tract (in contrast to systemic effects)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
2.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No repeated dose toxicity study with dermal application is available. Therefore an oral-to-dermal extrapolation is done.
AF for dose response relationship:
1
Justification:
default assessment factor
AF for differences in duration of exposure:
2
Justification:
default value for time extrapolation from sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
default value for correction for differences in metabolic rate (rat to humans)
AF for intraspecies differences:
5
Justification:
default assessment factor
AF for the quality of the whole database:
1
Justification:
guideline study
AF for remaining uncertainties:
1
Justification:
toxicodynamic differences between humans and rats are not assumed; therefore the assessment factor for remaining differences is set to 1
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

According to "ECHA Guidance on IR/CSR Chapter R.8" (ECHA-2010-G-19-EN, Nov. 2012), when no DNEL can be derived, a qualitative approach to assessing and controlling the risks is necessary. In case of the DMDC there are no adequate dose-response data available which would allow the derivation of the DNEL for dermal local effects. Thus, based on the substance's classification as corrosive (Category 1A, H314) it is allocated to the high hazard band and appropriate Risk Management Measures and Operational Conditions are needed (acc. to ECHA Guidance on IR/CSR Part E, Nov. 2012).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

Currently, a consumer use of DMDC is not foreseen. Therefore, a DNEL derivation was not performed. Since no consumer use is planned, a derivation of the DNELs for general population does not affect risk characterization at all.