Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.58 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
Dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
39.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction factor for differences in bioavailability (ABS), inhalation vs. oral absorption: 1

Correction factor for differences in respiratory volume (SRV): 2.63 (1/0.38 m3/kg)

Correction factor for light activity at work (WORKER): 0.67 (6.7 m3/10 m3)

Correction for differences between human and experimental exposure conditions (EXPCOND): 1.4 (5 days/7 days)

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
2
Justification:
default AF
AF for interspecies differences (allometric scaling):
1
Justification:
not needed
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.54 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
62.5
Dose descriptor starting point:
LOAEC
DNEL value:
284 mg/m³
Modified dose descriptor starting point:
LOAEC
DNEL value:
284 mg/m³
AF for dose response relationship:
5
Justification:
extrapolation of the NOAEC from the LC0
AF for interspecies differences (allometric scaling):
1
Justification:
not needed
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.54 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
62.5
Dose descriptor starting point:
LOAEC
DNEL value:
284 mg/m³
AF for dose response relationship:
5
Justification:
extrapolation of the NOAEC from the LOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
not needed
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.24 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):
100
Dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
224 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction factor for differences in bioavailability (ABS), oral vs. dermal absorption: 10 (The available data suggests that sodium thioglycolate and thioglycolic acid are readily absorbed by oral administration. However, based on the acute toxicity and skin penetration studies, it seems that the absorption of thioglycolic acid is significantly lower by dermal route than by oral administration and an assessment factor of 10 is used to take into account this difference of absorption)

Correction for differences between human and experimental exposure conditions (EXPCOND): 1.4 (5 days/7 days)

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
2
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
DNEL (Derived No Effect Level)
Value:
0.28 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
Dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
13.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction factor for differences in bioavailability (ABS), inhalation vs. oral absorption: 1

Correction factor for differences in respiratory volume (SRV): 0.87 (1/1.15 m3/kg)

Correction for differences between human and experimental exposure conditions (EXPCOND): 1

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
DNEL (Derived No Effect Level)
Value:
0.8 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
Dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
160 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction factor for differences in bioavailability (ABS), oral vs. dermal absorption: 10 (The available data suggests that sodium thioglycolate and thioglycolic acid are readily absorbed by oral administration. However, based on the acute toxicity and skin penetration studies, it seems that the absorption of thioglycolic acid is significantly lower by dermal route than by oral administration and an assessment factor of 10 is used to take into account this difference of absorption)

Correction for differences between human and experimental exposure conditions (EXPCOND): 1

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 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
Dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
16 mg/kg bw/day
AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
2
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
10
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
medium 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