Registration Dossier

Diss Factsheets

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:
medium 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:
1.04 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:
medium 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.

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