Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.53 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):
75
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264.47 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of the starting point.


Key study selected: OECD 407 study performed with undecylenoyl glycine => NOAEL for systemic toxicity = 150 mg/kg bw/d.


corrected inhalatory NOAEC = 150 x 1/0.38 x 6.7/10 = 264.47 mg/m3


(assuming 100 % absorption for both routes in both species)


Correction for inhalation to oral absorption: no factor is added. Justification: the test substance has a low volatility (vapour pressure of less than 0.5 kPa). - No difference in oral and inhalation absorption is expected between rats and human

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
duration extrapolation from subacute to chronic: 6
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric factor for inhalation
AF for other interspecies differences:
2.5
Justification:
remaining differences: 2.5 as described in the ECHA guidance R8.
AF for intraspecies differences:
5
Justification:
5 for workers as described in ECHA guidance R8
AF for the quality of the whole database:
1
Justification:
Well conducted OECD 407 study with the registered substance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low 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:
0.5 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):
300
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

oral absorption rat = oral absorption human


assuming 100 % absorption for both routes in both species

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Duration extrapolation factor for subacute to chronic according to ECHA guidance R8: 6
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric factor between rats and humans according to ECHA guidance R8: 4
AF for other interspecies differences:
2.5
Justification:
Remaining interspecies differences factor of 2,5 according to ECHA guidance R8
AF for intraspecies differences:
5
Justification:
intraspecies differences factor of 5 for workers (ECHA guidance R8)
AF for the quality of the whole database:
1
Justification:
OECD 407 key study: Well conducted study
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

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

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

Local effects

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

General Population - Hazard via dermal route

Systemic effects

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

Local effects

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

General Population - Hazard via oral route

Systemic effects

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population