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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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