Registration Dossier
Registration Dossier
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EC number: 203-336-8 | CAS number: 105-83-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Performance of the study was waived. Calculation was based on worst-case.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: sub-acute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not applied because the ventilation rate directly depends on the basal metabolic rate.
- AF for other interspecies differences:
- 1
- Justification:
- There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used (ECETOC).
- AF for intraspecies differences:
- 3
- Justification:
- The (ECETOC) default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach of the DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: sub-acute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling is applied.
- AF for other interspecies differences:
- 1
- Justification:
- There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used (ECETOC).
- AF for intraspecies differences:
- 3
- Justification:
- The (ECETOC) default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The qualitiy of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach of the DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNELs for systemic effects (short and long-term exposure)
The information related to acute/short-term and long-term exposure hazards via the different exposure routes has been already commented/discussed above.
DNELs for local effects (short and long-term exposure)
The information related to acute/short-term and long-term exposure hazards via the different exposure routes has been already commented/discussed above. Due to the corrosive potential of N,N-bis(3 -aminopropyl)methylamine respiratory irritation following inhalation exposure is likely. However, there are no substance specific data on respiratory irritation available. Therefore, it is necessary to stipulate risk management measures to prevent exposure.
General Population - Hazard via inhalation 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
Local 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 via dermal 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
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
N,N-bis(3-aminopropyl)methylamin is exclusively handled by industrial and professional workers. Due to this, no DNELs have to be derived for the general population.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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