Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: 800-153-0 | CAS number: 1313206-64-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.035 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:
- 0.7 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subchronic) = 0.7 mg/kg bw/day
Correction factor for differences in respiratory volume (rat/workers): 1/0.38
Correction factor for light activity at work: 6.7/10
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Absorptions by inhalation and oral route are not known, therefore it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
NOAEC = NOAEL x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 0.7 x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 0.86- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- 0.01 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.7 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.98 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subchronic) = 0.7 mg/kg bw/day
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Absorptions by dermal and oral routes are not known, therefore it was considered that oral absorption in the rat was equivalent to human absorption via the dermal route in accordance with ECHA Guidance.
NOAEL = NOAEL x 1 x 7/5 = 0.7 x 1 x 7/5 = 0.98- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 0.006 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:
- 0.7 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subchronic) = 0.7 mg/kg bw/day
Correction factor for differences in respiratory volume (rat/general population): 1/1.15
Absorptions by inhalation and oral route are not known, therefore it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
NOAEC = NOAEL x (1/1.15) x 0.5 = 0.7 x (1/1.15) x 0.5 = 0.30- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.7 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL (oral route, subchronic) = 0.7 mg/kg bw/day
Absorptions by dermal and oral routes are not known, therefore it was considered that oral absorption in the rat was equivalent to human absorption via the dermal route in accordance with ECHA Guidance.
NOAEL = NOAEL x 1 = 0.7 x 1 = 0.7- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.004 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point is required.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The key study chosen for DNEL calculation is considered as a reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
