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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.736 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
1 586.84 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC: 1800 mg/kg bw/day *(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) = 1586.84 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL value. The predicted NOAEL value for tridecanedioic acid (CAS No. 505-52-2) is derived from a read-across dodecanedioic acid (CAS 693-23-2) subchronic repeated dose toxicity study (key study RL2, supporting study RLX). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
1 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 1800 mg/kg bw/day * (ABSoral/ABSdermal)=1800 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human in dermal route, Allometric scaling is 4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for tridecanedioic acid (CAS No. 505-52-2) is derived from a read-across dodecanedioic acid (CAS 693-23-2) subchronic repeated dose toxicity study (key study RL2, supporting study RLX). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
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:
low 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:
7.82 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):
100
Modified dose descriptor starting point:
NOAEC
Value:
782.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEC: 1800 mg/kg bw/day * (1/1.15 m3/kg/d)*(ABSoral/ABSinh.) = 782.60 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL value. The predicted NOAEL value for tridecanedioic acid (CAS No. 505-52-2) is derived from a read-across dodecanedioic acid (CAS 693-23-2) subchronic repeated dose toxicity study (key study RL2, supporting study RLX). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
4.5 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
1 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 1800 mg/kg bw/day * (ABSoral/ABSdermal)=1800 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human in dermal route, Allometric scaling is 4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for tridecanedioic acid (CAS No. 505-52-2) is derived from a read-across dodecanedioic acid (CAS 693-23-2) subchronic repeated dose toxicity study (key study RL2, supporting study RLX). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
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:
4.5 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
1 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
None required
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
2 subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
4 rat to human in oral route, Allometric scaling is 4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for tridecanedioic acid (CAS No. 505-52-2) is derived from a read-across dodecanedioic acid (CAS 693-23-2) subchronic repeated dose toxicity study (key study RL2, supporting study RLX). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
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:
low hazard (no threshold derived)

Additional information - General Population