Registration Dossier
Registration Dossier
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EC number: 679-526-3 | CAS number: 337906-36-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.08 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:
- other: NOEC
- Value:
- 27.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Toxicokinetics data for rats indicate an bioavailability of 1,4-diamino-2-methoxymethyl-benzene sulfate by intravenous and oral routes. The route to route extrapolation from oral study to inhalation study could be used.
The oral bioavailability of 2-METHOXY-METHYL-P-PHENYLENEDIAMINE SULFATE, based on the AUC, was high and comparable to the AUC after i.v. administration. When calculated from the urine data from the mass balance groups, the oral bioavailability was 99% at 25 mg/kg bw and 84% at 100 mg/kg bw. The inhalation absorption was considered by default to be 100%.
- 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 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 48.06 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):
- 12.5
- Modified dose descriptor starting point:
- other: MTD
- Value:
- 600.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Toxicokinetics data for rats indicate an bioavailability of 1,4-diamino-2-methoxymethyl-benzene sulfate by intravenous and oral routes. The route to route extrapolation from oral study to inhalation study could be used.
The oral bioavailability of 2-METHOXY-METHYL-P-PHENYLENEDIAMINE SULFATE, based on the AUC, was high and comparable to the AUC after i.v. administration. When calculated from the urine data from the mass balance groups, the oral bioavailability was 99% at 25 mg/kg bw and 84% at 100 mg/kg bw. The inhalation absorption was considered by default to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- MTD is considered as relevant as a NOAEL
- 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:
- defaut 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:
- 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:
- 0.732 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
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 73.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Toxicokinetics data for rats indicate an bioavailability of 1,4-diamino-2-methoxymethyl-benzene sulfate by intravenous and oral routes. The route to route extrapolation from oral study to dermal study could be used.
The oral bioavailability of 2-METHOXY-METHYL-P-PHENYLENEDIAMINE SULFATE, based on the AUC, was high and comparable to the AUC after i.v. administration. When calculated from the urine data from the mass balance groups, the oral bioavailability was 99% at 25 mg/kg bw and 84% at 100 mg/kg bw. The inhalation absorption was considered by default to be 100%.
The average dermal absorption was low in the dermal dose groups, and was 2.0% (0.5 h exposure) at 24 mg/kg bw and 21% (24 hour exposure) at 100 mg/kg bw.
- 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 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 71.7 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:
- DNEL (Derived No Effect Level)
- Value:
- 71.7 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:
- EC 3 value acn 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:
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - 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
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