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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The only study available used repeated oral treatment, no study using repeated inhalation is available

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for differences in duration of exposure:
6
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
3
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
294 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC
DNEL value:
3 526 mg/m³
Explanation for the modification of the dose descriptor starting point:

The only study available used oral treatment, No study using inhalation is available

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
Default factor proposed by ECHA
AF for intraspecies differences:
3
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The only repeated dose study available used oral treatment, No study using repeated dermal exposure is available

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for differences in duration of exposure:
6
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
Default factor proposed by ECHA
AF for intraspecies differences:
3
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
167 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No extrapolation used

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
Default factor proposed by ECHA
AF for intraspecies differences:
3
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

None of the available toxicity studies indicates a relevant hazard. The derived No-Effect-Levels (DNEL) are expected to ensure safe use for all workers. As there are no hazards relevant for classification, no steps were taken to evaluate risks.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The only repeated dose study available used oral treatment, No study using repeated dermal exposure is available.

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for differences in duration of exposure:
6
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
176 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The only repeated dose study available used oral treatment, No study using repeated dermal exposure is available.

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA

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:
DNEL (Derived No Effect Level)
Value:
8.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The only repeated dose study available used oral treatment, No study using repeated dermal exposure is available

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for differences in duration of exposure:
6
Justification:
Default factor proposed by ECETOC
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL derived from an acute dermal toxicity study was used

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL of the available subacute oral study in rats was used

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for differences in duration of exposure:
6
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance & ECETOC TR 110
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
DNEL value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL of the available acute oral study in rats was used

AF for dose response relationship:
1
Justification:
Default factor proposed by ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat-human allometric scaling factor proposed by ECHA
AF for other interspecies differences:
1
Justification:
According to ECETOC technical Report 110 remaining differences are inclosed in the allometric extrapolation
AF for intraspecies differences:
5
Justification:
Default factor proposed by ECETOC
AF for the quality of the whole database:
1
Justification:
Default factor proposed by ECHA
AF for remaining uncertainties:
1
Justification:
Default factor proposed by ECHA

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

In almost all available studies the test item showed no adverse efffects. The only exception being the acute eye irritation study, where mild temporary effects were seen in one of three animals, which were not sufficient for classification. Therefore only a very small hazard is anticipated. In combination with the very limited exposure potential no significant risk is expected. Nevertheless, DNELs were calculated for workers and the general population.