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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-929-9 | CAS number: 68391-11-7 The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 38 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 380 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEC long-term, inhalation was 380 mg/m3, determined in a sub-chronic repeated dose toxicity study (see IUCLID section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- Default with NOAEL value as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable.
- AF for other interspecies differences:
- 1
- Justification:
- No indication of toxicokinetic or toxicodynamic differences between species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data base.
- AF for remaining uncertainties:
- 1
- Justification:
- No uncertainties remaining.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A NOAEL long-term, dermal of 30 mg/kg bw/day (see IUCLID section 7.5.1) was calculated from a NOEL long-term, oral of 30 mg/kg bw/day, assuming 100 % resorption through the skin.
- AF for dose response relationship:
- 1
- Justification:
- Default with NOEC value as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor (rat)
- AF for other interspecies differences:
- 1
- Justification:
- No indication of toxicokinetic or toxicodynamic differences between species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data base.
- AF for remaining uncertainties:
- 1
- Justification:
- No uncertainties remaining.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNEL derivation for the test item was limited to long-term DNELs, as peak exposures are not expected. Further, only systemic effects were considered, as available data on local effects does not allow derivation of local DNELs. Instead a quantitative risk assessment was carried out for local effects following potential exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 380 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEC long-term, inhalation was 380 mg/m3, determined in a sub-chronic repeated dose toxicity study (see IUCLID section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- Default with NOAEL value as starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable.
- AF for other interspecies differences:
- 1
- Justification:
- No indication of toxicokinetic or toxicodynamic differences between species.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general public.
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data base.
- AF for remaining uncertainties:
- 1
- Justification:
- No uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.125 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A NOAEL long-term, dermal of 30 mg/kg bw/day was calculated from a NOAEL long-term, oral of 30 mg/kg bw/day (see IUCLID section 7.5.1).
- AF for dose response relationship:
- 1
- Justification:
- Default with NOAEL value as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor (rat).
- AF for other interspecies differences:
- 1
- Justification:
- No indication of toxicokinetic or toxicodynamic differences between species.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general public.
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data base.
- AF for remaining uncertainties:
- 1
- Justification:
- No uncertainties remaining.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.125 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL long-term, oral was 30 mg/kg bw/day, determined in a repeated dose toxicity oral study (see IUCLID section 7.5.1).
- AF for dose response relationship:
- 1
- Justification:
- Default with NOAEL value as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor (rat).
- AF for other interspecies differences:
- 1
- Justification:
- No indication of toxicokinetic or toxicodynamic differences between species.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general public.
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data base.
- AF for remaining uncertainties:
- 1
- Justification:
- No uncertainties remaining.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation for the test item was limited to long-term DNELs, as peak exposures are not expected. Further, only systemic effects were considered, as available data on local effects does not allow derivation of local DNELs. Instead a quantitative risk assessment was carried out for local effects following potential exposure.
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.
