Registration Dossier
Registration Dossier
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EC number: 202-442-1 | CAS number: 95-70-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.27 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to the 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:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- default value for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation from oral to inhalation route (example B3 of guidance R8)
- AF for other interspecies differences:
- 2.5
- Justification:
- R8 ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2 because data on 2,5-toulene diamine sulphate
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 125
- Modified dose descriptor starting point:
- other: LOAEL
- Value:
- 130 mg/m³
- 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:
- Extrapolation from oral to inhalation route (example B3 of guidance R8)
- 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 2 because data on 2,5-toulene diamine sulphate
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.759 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):
- 250
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 189.75 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- default value for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- default value
- AF for other interspecies differences:
- 4
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2 because data on 2,5-toulene diamine sulphate
- AF for remaining uncertainties:
- 2.5
- Justification:
- uncertainty in bioavailability on skin between analogue 2,5-toulene diamine sulphate and 2,5-toulene diamine
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.84 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:
- EC3 value can be considered as LOAEL for induction (R8 guidance document) maximum factor
- AF for differences in duration of exposure:
- 1
- Justification:
- not concerned
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not concerned
- 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
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.84 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- EC3 value can be considered as LOAEL for induction (R8 guidance document) maximum factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not concerned
- AF for other interspecies differences:
- 1
- Justification:
- not concerned
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The substance has been shown inin vitroandin vivostudy to be severely irritant for the eyes and classified H318 according to CLP criteria. H318: Causes serious eye damage. Discussion No DNEL could be derived but qualitative approach is recommended. According to irritant effect on the eyes, risk management measures should be considered for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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.
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