Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-100-7 | CAS number: 115-69-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.17 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 439.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 387.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
From an oral OECD 422 study in rats with the read-across substance AEPD, an NOAEL of 500 mg/kg bw is available. This was corrected for the MW of AMPD to 439.5 mg/kg bw. This NOAEL was converted to an inhalation NOAEC for workers via the formula:
Inhalation NOAEC = oral NOAEL * (1/0.38 m3/kg/d) * 0.67 * (ABS oral/ABS inh.). It is assumed that the oral absorption rate is 50% of the inhalation rate.
Therefore, the inhalation NOAEC = 439.5 * (1/0.38) * 0.67* (0.5/1) = 387.5 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute study (OECD 422) to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not applied for the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.66 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 439.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 098.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From an oral OECD 422 study with the read-across susbstance AEPD, an NOAEL of 500 mg/kg bw is available. This was corrected for the MW of AMPD to 439.5 mg/kg bw. This NOAEL was converted to a dermal NOAEL via the formula:
Dermal NOAEC = oral NOAEL * (ABS oral/ABS dermal). It is assumed that the dermal absorption rate is 40% of the oral absorption rate.
Therefore, the dermal NOAEC = 439.5 * (1/0.4) = 1098.75 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute study (OECD 422) to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for workers according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for workers according to ECHA Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.274 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 439.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 191.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
From an oral OECD 422 study in rats with the read-across substance AEPD, an NOAEL of 500 mg/kg bw is available. This was corrected for the MW of AMPD to 439.5 mg/kg bw. This NOAEL was converted to an inhalation NOAEC for the general population via the formula:
Inhalation NOAEC = oral NOAEL * (1/1.15 m3/kg/d) * (ABS oral/ABS inh.). It is assumed that the oral absorption rate is 50% of the inhalation rate.
Therefore, the inhalation NOAEC = 439.5 * (1/1.15) * (0.5/1) = 191.1 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute study (OECD 422) to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not applied for the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.83 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 439.5 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 098.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From an oral OECD 422 study witht the read-across substance AEPD, an NOAEL of 500 mg/kg bw is available. This was corrected for the MW of AMPD to 439.5 mg/kg bw. This NOAEL was converted to a dermal NOAEL for the genearal population via the formula:
Dermal NOAEC = oral NOAEL * (ABS oral/ABS dermal). It is assumed that the dermal absorption rate is 40% of the oral absorption rate.
Therefore, the dermal NOAEC = 439.5 * (1/0.4) = 1098.75 mg/m3.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute study (OECD 422) to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.733 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 439.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
From an oral OECD 422 study in rats with the read-across substance AEPD, an NOAEL of 500 mg/kg bw is available. This was corrected for the MW of AMPD to 439.5 mg/kg bw.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute study (OECD 422) to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population according to ECHA Guidance.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
