Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.88 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):
10
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
8.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL was corrected for respiratory volume and increased breathing during light activity:

5/0.38*(6.7/10) = 8.8

Due to its lipophilic properties, micellular solubilisation will occur after oral and inhalation uptake. Since the low molelcular weight additionally allows oral uptake via aquaeous pores, absorption will be complete and no higher assumed uptake after inhalation exposure seems justified.

AF for dose response relationship:
1
Justification:
NOAEL identified
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
1
Justification:
The NOAEL was conservatively set at the lowest dose due to reduced body weight in males and poor general state in single animals only (piloerection, respiratory sounds). These effects are likely secondary to bad taste, local irritation, and/or changes in stomach pH values. Additonally, toxicokinetic aspects like extensive metabolism - as observed in the high dose - and potential transport of the test substance into the lung - based on a metabolism study in mice - might have added to the poor general state. But no changes in blood or urine parameters were oberserved, nor were there any histopathological findings. In the absence of any specific toxicity, a conservatively set NOAEL, and since all observed effects can be explained either by local toxicity or toxicodynamic processes, an additional factor for toxicodynamic differences seems unjustified.
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 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):
40
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No differences between oral and dermal absorption is assumed.

AF for dose response relationship:
1
Justification:
NOAEL identified
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human
AF for other interspecies differences:
1
Justification:
The NOAEL was conservatively set at the lowest dose due to reduced body weight in males and poor general state in single animals only (piloerection, respiratory sounds). These effects are likely secondary to bad taste, local irritation, and/or changes in stomach pH values. Additonally, toxicokinetic aspects like extensive metabolism - as observed in the high dose - and potential transport of the test substance into the lung - based on a metabolism study in mice - might have added to the poor general state. But no changes in blood or urine parameters were oberserved, nor were there any histopathological findings. In the absence of any specific toxicity, a conservatively set NOAEL, and since all observed effects can be explained either by local toxicity or toxicodynamic processes, an additional factor for toxicodynamic differences seems unjustified.
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
no hazard identified
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:
no hazard identified
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:
0.063 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):
80
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL identified
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default rat to human
AF for other interspecies differences:
1
Justification:
The NOAEL was conservatively set at the lowest dose due to reduced body weight in males and poor general state in single animals only (piloerection, respiratory sounds). These effects are likely secondary to bad taste, local irritation, and/or changes in stomach pH values. Additonally, toxicokinetic aspects like extensive metabolism - as observed in the high dose - and potential transport of the test substance into the lung - based on a metabolism study in mice - might have added to the poor general state. But no changes in blood or urine parameters were oberserved, nor were there any histopathological findings. In the absence of any specific toxicity, a conservatively set NOAEL, and since all observed effects can be explained either by local toxicity or toxicodynamic processes, an additional factor for toxicodynamic differences seems unjustified.
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Justification for not deriving consumer based DNELs:

Tridecylamine is not sold for direct consumer use, but is used to make products used by the public. The use of Tridecylamine is mainly as an intermediate where no residual levels can be expected.