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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.681 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
Modified dose descriptor starting point:
NOAEC
Value:
17.02 mg/m³
AF for dose response relationship:
1
Justification:
(Default (DNEL calculator))
AF for differences in duration of exposure:
2
Justification:
(Default (DNEL calculator))
AF for interspecies differences (allometric scaling):
1
Justification:
(Default (DNEL calculator))
AF for other interspecies differences:
2.5
Justification:
(Default (DNEL calculator))
AF for intraspecies differences:
5
Justification:
(Default (DNEL calculator))
AF for the quality of the whole database:
1
Justification:
(Default (DNEL calculator))
AF for remaining uncertainties:
1
Justification:
(not concerned)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.75 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Modified dose descriptor starting point:
LOAEC
Explanation for the modification of the dose descriptor starting point:

According to toxicokinetic data for Sprague-Dawley rats, that indicate oral availability of toluene-2,5-diamine at 10 mg/kg bw to be 69%. The route to route extrapolation from oral study to inhalation study could be used. This is also the consideration of SCCS evaluation.

AF for dose response relationship:
10
Justification:
(the LOAEL taken from the acute oral toxicity is related to lethality as most severe effect)
AF for interspecies differences (allometric scaling):
1
Justification:
(default value)
AF for other interspecies differences:
2.5
Justification:
(default value)
AF for intraspecies differences:
5
Justification:
(default value for workers)
AF for the quality of the whole database:
1
Justification:
(reliability 1)
AF for remaining uncertainties:
1
Justification:
(not concerned)

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:
3.45 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

No difference in exposure for workers

AF for dose response relationship:
1
Justification:
(Default (DNEL calculator))
AF for differences in duration of exposure:
2
Justification:
(Default (DNEL calculator))
AF for interspecies differences (allometric scaling):
4
Justification:
(Default (DNEL calculator))
AF for other interspecies differences:
2.5
Justification:
(Default (DNEL calculator))
AF for intraspecies differences:
5
Justification:
(Default (DNEL calculator))
AF for the quality of the whole database:
1
Justification:
(Default (DNEL calculator))
AF for remaining uncertainties:
1
Justification:
(not concerned)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
5.2 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
other: EC3
AF for dose response relationship:
3
Justification:
(maximum factor)
AF for differences in duration of exposure:
1
Justification:
(not concerned)
AF for interspecies differences (allometric scaling):
1
Justification:
(maximum factor)
AF for other interspecies differences:
1
Justification:
(default factor)
AF for intraspecies differences:
5
Justification:
(default value for worker)
AF for the quality of the whole database:
1
Justification:
(reliability 1)
AF for remaining uncertainties:
1
Justification:
(not concerned)
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
5.2 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: EC3
AF for dose response relationship:
3
Justification:
(maximum factor)
AF for interspecies differences (allometric scaling):
1
Justification:
(maximum factor)
AF for other interspecies differences:
1
Justification:
(default value)
AF for intraspecies differences:
5
Justification:
(default value for worker)
AF for the quality of the whole database:
1
Justification:
(reliability 1)
Justification:
(not concerned)

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:
0.12 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
AF for dose response relationship:
1
Justification:
(Default (DNEL calculator))
AF for differences in duration of exposure:
2
Justification:
(Default (DNEL calculator))
AF for interspecies differences (allometric scaling):
1
Justification:
(Default (DNEL calculator))
AF for other interspecies differences:
2.5
Justification:
(Default (DNEL calculator))
AF for intraspecies differences:
10
Justification:
(Default (DNEL calculator))
AF for the quality of the whole database:
1
Justification:
(Default (DNEL calculator))
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:
1.73 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
AF for dose response relationship:
1
Justification:
(Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
(Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
(Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
(Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
(Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
(Default (DNEL calculator)
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
(Default (DNEL calculator))
AF for differences in duration of exposure:
2
Justification:
(Default (DNEL calculator))
AF for interspecies differences (allometric scaling):
4
Justification:
(Default (DNEL calculator))
AF for other interspecies differences:
2.5
Justification:
(Default (DNEL calculator))
AF for intraspecies differences:
10
Justification:
(Default (DNEL calculator))
AF for the quality of the whole database:
1
Justification:
(Default (DNEL calculator))
Acute/short term exposure
Hazard assessment conclusion:
medium 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