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Registration Dossier
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EC number: 292-588-2 | CAS number: 90640-67-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.54 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):
- 30
- Dose descriptor starting point:
- LOAEL
- Value:
- 33 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 16.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral LOAEL observed in a chronic repeated dose oral toxicity study (Yanagisawa, 1998).
To correct the interspecies difference between rat and human the lowest observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers:
= LOAEL(oral) * (1/0.38 m³/kg bw/day) * (ABSoral-rat/ABSinh-human) * 6.7 m³ (8h) /10 m³ (8h) * (7 days of exposure rat/5 days of exposure worker)
= 33 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (20%/100%) * 0.67 m³ * 1.4= 16.3 mg/m³
For intestinal absorption a figure of 20% has been estimated (based on rat data). Inhalation absorption was estimated to be 100% (no data).
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Thus, the corrected starting point for workers was 16.3 mg/m³ for inhalation.
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL. 50 mg TETA.2HCl/kg bw/day (corresponding to 33 mg Amines, polyethylenepoly-, triethylenetetramine fraction/kg bw/day was a NOAEL in females but a LOAEL in males.
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable
- AF for other interspecies differences:
- 1
- Justification:
- rats and dogs showed similar NOAELs following 26 weeks of exposure; mice showed a 2-times higher NOAEL at a 2-times shorter duration (13 weeks), indicating that interspecies effect concentrations are small if at all
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- no additional assessment factor is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.096 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 33 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral LOAEL observed in a chronic repeated dose oral toxicity study (Yanagisawa, 1998).
To correct the interspecies difference between rat and human the lowest observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for general population:
= LOAEL(oral) * (1/1.15 m³/kg bw/day(24h)) * (ABSoral-rat/ABSinh-human)
= 33 mg/kg bw/day * (1/1.15 m³/kg bw/day) * (20%/100%) = 5.7 mg/m³
For intestinal absorption a figure of 20% has been estimated (based on rat data). Inhalation absorption was estimated to be 100% (no data).
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Thus, the corrected starting point for workers was 5.7 mg/m³ for inhalation.
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL. 50 mg TETA.2HCl/kg bw/day (corresponding to 33 mg Amines, polyethylenepoly-, triethylenetetramine fraction/kg bw/day) was a NOAEL in females but a LOAEL in males.
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable
- AF for other interspecies differences:
- 1
- Justification:
- rats and dogs showed similar NOAELs following 26 weeks of exposure; mice showed a 2-times higher NOAEL at a 2-times shorter duration (13 weeks), indicating that interspecies effect concentrations are small if at all
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- no additional assessment factor is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 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):
- 240
- Dose descriptor starting point:
- LOAEL
- Value:
- 33 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL. 50 mg TETA.2HCl/kg bw/day (corresponding to 33 mg Amines, polyethylenepoly-, triethylenetetramine fraction/kg bw/day) was a NOAEL in females but a LOAEL in males.
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The experimental animal was a rat.
- AF for other interspecies differences:
- 1
- Justification:
- rats and dogs showed similar NOAELs following 26 weeks of exposure; mice showed a 2-times higher NOAEL at a 2-times shorter duration (13 weeks), indicating that interspecies effect concentrations are small if at all
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- no additional assessment factor is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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