Registration Dossier
Registration Dossier
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EC number: 263-502-0 | CAS number: 62314-22-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.15 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:
- 61 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 53.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The Point of departure is is based on the findings in two 90 day repeat dose oral toxicity studies in rats and mice using the dissociation product 2-Ethylhexanoic acid (2-EHA), where the lowest NOAEL of 61mg/kg/bw was derived from liver effects in male rats.The principal effects of 2-EHA involved the liver or metabolic processes associated with the liver.
Workers:
Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38m3/kg/d)*0.67*(ABSoral/ABSinhuman)
This yields a NOECcorr of 61mg/kg/d*(1/0.38 m3/kg/d)*0.67*(0.5*1)
= 61 * 2.63 * 0.67 * 0.5
= 53.7 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:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- rat to human inhalation
- AF for other interspecies differences:
- 1
- Justification:
- NOECcorr as starting point
- 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:
- 6.45 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 TMR is classified for acute effects of skin and eye corrosion, and is anticipated to be a respiratory irritant.
Concerning exposure to Dabco TMR, 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:2.15 x 3 =6.45 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:
- 0.53 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:
- 61 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.5 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- starting point corrected NOAEC from NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic 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
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