Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.82 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
24.7 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 no 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)

= 50 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (20%/100%) * 0.67 m³ * 1.4= 24.7 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 24.7 mg/m³ for inhalation.

AF for dose response relationship:
3
Justification:
The dose descriptor starting point is based on a LOAEL. 50 mg/kg bw TETA.2HCL 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:
0.14 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
8.7 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 no 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)

= 50 mg/kg bw/day * (1/1.15 m³/kg bw/day) * (20%/100%) = 8.7 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 8.7 mg/m³ for inhalation.

AF for dose response relationship:
3
Justification:
The dose descriptor starting point is based on a LOAEL. 50 mg/kg bw TETA.2HCL 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:
0.21 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:
50 mg/kg bw/day
AF for dose response relationship:
3
Justification:
The dose descriptor starting point is based on a LOAEL. 50 mg/kg bw TETA.2HCL 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