Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.75 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Workers:

Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38m3/kg/d)*0.67*(ABSoral/ABSinhuman)

 

This yields a NOECcorr of 1000mg/kg/d*(1/0.38 m3/kg/d)*0.67*(0.5*1)

= 1000 * 2.63 * 0.67 * 0.5

 

= 881.5 mg/m3= NOECcorr Workers

Based on: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14

https://echa.europa.eu/documents/10162/13655/pg_14_on_hazard_endpoint_en.pdf

AF for dose response relationship:
1
Justification:
starting point NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat to human inhalgtion
AF for intraspecies differences:
5
Justification:
ECHA defaullt - worker
AF for the quality of the whole database:
1
Justification:
Sufficient to determine health outcomes
AF for remaining uncertainties:
2.5
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

DNELs for acute effects are recommended to be derived if an acute toxicity hazard (leading to classification and labelling) has been identifiedandthere is a potential for high peak exposure (R.8. 1.2.5, p. 16). Dabco TMR2 is classified for acute effects of skin and eye corrosion, and is anticipated to be a respiratory irritant.

 

Concerning exposure to Dabco TMR2, in the scenarios reported by users, there may be opportunities for short intermittent dermal or inhalation exposure in the workplace, such as during sampling or transferring material. The low vapour pressure of the substance maybe a mitigating factor in exposures. Oral exposure is deemed unlikely.  

 

According to the ECHA Guidance, Appendix R 8.8, there is “no accepted methodology for determining acute dermal exposures, and protection is generally accommodated by more conservative long-term systemic DNELs” (p. 106).

 

One well-established method used to estimate an acute threshold limit value (TLV) is the multiplication of the long-term DNEL by a factor of 3 (Guidance R.8, Appendix R.8.8, p. 110, 2008, equivalent to dividing by 0.33 as required in the IUCLID5 format). 

 

Therefore the following Acute Systemic DNELs are derived:

 

Worker:

Acute Systemic Inhalation:11.75 x 3 =35.25 mg/m3

 

It should be noted that, at exposures to these levels, a local irritant effect may already be obvious to the user. The amelioration of local skin/eye risks should provide an adequate degree of safety from systemic effects.

 

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

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

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:
2.9 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
starting point corrected NOAEC from NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Inhalation
AF for intraspecies differences:
10
Justification:
General Population - ECHA default
AF for the quality of the whole database:
1
Justification:
sufficient to determine health outcomes
AF for remaining uncertainties:
2.5
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population