Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.62 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):
16.32
Dose descriptor starting point:
other: NOEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
26.45 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOAELoral-rat -> corrected inhalative NOAEChuman (8h worker): NOAEC human (8h worker) = oral NOAEL rat (15 mg/kg bw/d) * 1 / sRVrat (0.38m³/kg/d) * ABSoral-rat (1)/ABSinh-human (1) * sRVhuman (6.7 m³)/wRV (10 m³) = 26.45 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is already a NOAEL/NOEL.
AF for differences in duration of exposure:
3.4
Justification:
The original study was a sub-acute (28-day) study and the assessment factor was used to correct for the differences of a sub-acute study to a chronic study (worst case scenario). The assessment factor proposed by Batke et al. (2001) "Evaluation of time extrapolation factors based on the database RepDose" was used.
AF for interspecies differences (allometric scaling):
1
Justification:
No AF for allometric scaling necessary as differences in metabolic rates have already been compensated for in the modification of the dose descriptor. Route-to-route extrapolation was performed within one species as a first step and interspecies extrapolation within the same exposure route as the second step.
AF for other interspecies differences:
1
Justification:
The study used for the calculation of the systemic long term DNEL obtained a NOEL and thus, no AF for other interspecies differences were applied. The value was considered sufficiently protective.
AF for intraspecies differences:
2.4
Justification:
Default value for worker proposed by Schneider et al. (2005) "Uncertainty Analysis on Workplace Effect Assessment".
AF for the quality of the whole database:
1
Justification:
The quality of the database is sufficient and reliable.
AF for remaining uncertainties:
2
Justification:
A default value for the route-to-route extrapolation from oral to inhalation.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
1.15 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):
32.64
Dose descriptor starting point:
other: NOEL
Value:
37.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAELoral-rat-> corrected dermal NOAELhuman : oral NOAEL rat (15 mg/kg bw/d) * ABSoral-rat (1)/ABSinh-human (0,4) =37.5 mg/kg bw/d

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is already a NOAEL/NOEL.
AF for differences in duration of exposure:
3.4
Justification:
The original study was a sub-acute (28-day) study and the assessment factor was used to correct for the differences of a sub-acute study to a chronic study (worst case scenario). The assessment factor proposed by Batke et al. (2001) "Evaluation of time extrapolation factors based on the database RepDose" was used.
AF for interspecies differences (allometric scaling):
4
Justification:
To correct for differences in species sensitivity. In the study used for assessment, the rat as species was chosen.
AF for other interspecies differences:
1
Justification:
The study used for the calculation of the systemic long term DNEL obtained a NOEL and thus, no AF for other interspecies differences were applied. The value was considered sufficiently protective.
AF for intraspecies differences:
2.4
Justification:
Default value for worker proposed by Schneider et al. (2005) "Uncertainty Analysis on Workplace Effect Assessment".
AF for the quality of the whole database:
1
Justification:
The quality of the database is sufficient and reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
0.5 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):
25.84
Dose descriptor starting point:
other: NOEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13.04 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOAELoral-rat -> corrected inhalative NOAEChuman (24 h general population): NOAEC human (24 h general populatoin) = oral NOAEL rat (15 mg/kg bw/d) * 1 / sRVrat (1.15 m³/kg/d) * ABSoral-rat (1)/ABSinh-human (1) =13.04 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is already a NOAEL/NOEL.
AF for differences in duration of exposure:
3.4
Justification:
The original study was a sub-acute (28-day) study and the assessment factor was used to correct for the differences of a sub-acute study to a chronic study (worst case scenario). The assessment factor proposed by Batke et al. (2001) "Evaluation of time extrapolation factors based on the database RepDose" was used.
AF for interspecies differences (allometric scaling):
1
Justification:
No AF for allometric scaling necessary as differences in metabolic rates have already been compensated for in the modification of the dose descriptor using a standard breathing volume for the rat.
AF for other interspecies differences:
1
Justification:
The study used for the calculation of the systemic long term DNEL obtained a NOEL and thus, no AF for other interspecies differences were applied. The value was considered sufficiently protective.
AF for intraspecies differences:
3.8
Justification:
Default value for the general population proposed by Schneider et al. (2005) "Uncertainty Analysis on Workplace Effect Assessment".
AF for the quality of the whole database:
1
Justification:
The quality of the database is sufficient and reliable.
AF for remaining uncertainties:
2
Justification:
A default value for the route-to-route extrapolation from oral to inhalation.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.73 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):
51.68
Dose descriptor starting point:
other: NOEL
Value:
37.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAELoral-rat-> corrected dermal NOAELhuman : oral NOAEL rat (15 mg/kg bw/d) * ABSoral-rat (1)/ABSinh-human (0.4) =37.5 mg/kg bw/d

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is already a NOAEL/NOEL.
AF for differences in duration of exposure:
3.4
Justification:
The original study was a sub-acute (28-day) study and the assessment factor was used to correct for the differences of a sub-acute study to a chronic study (worst case scenario). The assessment factor proposed by Batke et al. (2001) "Evaluation of time extrapolation factors based on the database RepDose" was used.
AF for interspecies differences (allometric scaling):
4
Justification:
To correct for differences in species sensitivity. In the study used for assessment, the rat as species was chosen.
AF for other interspecies differences:
1
Justification:
The study used for the calculation of the systemic long term DNEL obtained a NOEL and thus, no AF for other interspecies differences were applied. The value was considered sufficiently protective.
AF for intraspecies differences:
3.8
Justification:
Default value for the general population proposed by Schneider et al. (2005) "Uncertainty Analysis on Workplace Effect Assessment".
AF for the quality of the whole database:
1
Justification:
The quality of the database is sufficient and reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
0.3 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):
51.68
Dose descriptor starting point:
other: NOEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification necessary

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is already a NOAEL/NOEL.
AF for differences in duration of exposure:
3.4
Justification:
The original study was a sub-acute (28-day) study and the assessment factor was used to correct for the differences of a sub-acute study to a chronic study (worst case scenario). The assessment factor proposed by Batke et al. (2001) "Evaluation of time extrapolation factors based on the database RepDose" was used.
AF for interspecies differences (allometric scaling):
4
Justification:
To correct for differences in species sensitivity. In the study used for assessment, the rat as species was chosen.
AF for other interspecies differences:
1
Justification:
The study used for the calculation of the systemic long term DNEL obtained a NOEL and thus, no AF for other interspecies differences were applied. The value was considered sufficiently protective.
AF for intraspecies differences:
3.8
Justification:
Default value for the general population proposed by Schneider et al. (2005) "Uncertainty Analysis on Workplace Effect Assessment".
AF for the quality of the whole database:
1
Justification:
The quality of the database is sufficient and reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
medium hazard (no threshold derived)

Additional information - General Population

The substance is used in diverse consumer products as hair conditioning agent, surfactant in cleansing products, as foam booster, and hydrotrope. Dermal exposure is assumed to be the most relevant route of exposure.