Registration Dossier
Registration Dossier
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EC number: 242-838-1 | CAS number: 19147-16-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.94 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 126
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 875 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No inhalation study available.
- AF for dose response relationship:
- 6
- Justification:
- REACH Guidance Table R.8-6
- AF for differences in duration of exposure:
- 0.7
- Justification:
- REACH Guidance Table R.8-6
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- REACH Guidance Table R.8-6
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance Table R.8-6
- AF for intraspecies differences:
- 5
- Justification:
- REACH Guidance Table R.8-6
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance Table R.8-6
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:
- 1.98 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 126
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal studies available
- AF for dose response relationship:
- 6
- Justification:
- REACH Guidance Table R.8-6
- AF for differences in duration of exposure:
- 0.7
- Justification:
- REACH Guidance Table R.8-6
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- REACH Guidance Table R.8-6
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance Table R.8-6
- AF for intraspecies differences:
- 5
- Justification:
- REACH Guidance Table R.8-6
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance Table R.8-6
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:
- high hazard (no threshold derived)
Additional information - workers
Eye protection in mandatory when manipulating this substance
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.04 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 375 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No inhalation study available
- AF for dose response relationship:
- 6
- Justification:
- REACH Guidance Table R.8-6
- AF for differences in duration of exposure:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- REACH Guidance Table R.8-6
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance Table R.8-6
- AF for intraspecies differences:
- 10
- Justification:
- REACH Guidance Table R.8-6
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance Table R.8-6
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:
- 0.69 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal studies available
- AF for dose response relationship:
- 6
- Justification:
- REACH Guidance Table R.8-6
- AF for differences in duration of exposure:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- REACH Guidance Table R.8-6
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance Table R.8-6
- AF for intraspecies differences:
- 10
- Justification:
- REACH Guidance Table R.8-6
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance Table R.8-6
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:
- 0.69 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 6
- Justification:
- REACH Guidance Table R.8-6
- AF for differences in duration of exposure:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- REACH Guidance Table R.8-6
- AF for other interspecies differences:
- 2.5
- Justification:
- REACH Guidance Table R.8-6
- AF for intraspecies differences:
- 10
- Justification:
- REACH Guidance Table R.8-6
- AF for the quality of the whole database:
- 1
- Justification:
- REACH Guidance Table R.8-6
- AF for remaining uncertainties:
- 1
- Justification:
- REACH Guidance Table R.8-6
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Read-across approach
In the assessment of the toxicity of potassium adipate, a read-across approach from data for adipic acid (CAS 124 -04 -9; EC 204 -673 -3) is followed.
Once the individual constituents of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by the toxicity of the “individual” constituents. Since synergistic effects are not expected for this group of metal carboxylates, the human health hazard assessment consists of an individual assessment of the metal cation and the organic anion.
As potassium is the eighth or ninth most common element by mass (0.2%) in the human body (an adult of 60 kg adult contains a total of about 120 g of potassium), intake of potassium adipate is not expected to increase significantly the concentration in the human body.
Therefore hazard information was only considered from adipic acid. This information was obtained from existing REACH registration dossiers via a license-to-use obtained by the lead registrant. These registration dossiers were submitted to ECHA in 2010 as full registration dossiers, and are thus considered to contain relevant and reliable information for all human health endpoints. All lead-registrant dossiers were checked for completeness and accepted by ECHA, i.e. a registration number was assigned.
Based on the above information, unresistricted read-across is considered feasible and justified.
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.
