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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4.11 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):
150
Dose descriptor starting point:
LOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
617 mg/m³
Explanation for the modification of the dose descriptor starting point:

As there was no reproductive or developmental effect observed up to the highest dose tested (OECD 414), the LOAEL for repeated dose toxicity (OECD 408) where systemic toxicity was observed was used to derive the Long-term systemic DNEL.

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 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):
600
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance (default).

The default calculator is malfunctioning and does not allow to chose the LOAEL for repeated dose toxicity.

As there was no reproductive or developmental effect observed up to the highest dose tested (OECD 414), the LOAEL for repeated dose toxicity (OECD 408) where systemic toxicity was observed was used to derive the Long-term systemic DNEL.

AF for dose response relationship:
3
Justification:
Default (DNEL calculator). Starting point is a LOAEL.
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
180 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
other: NESIL derived from EC3 = 3.6%
Value:
900 µg/m³
AF for dose response relationship:
1
Justification:
According to ECHA Guidance (default)
AF for differences in duration of exposure:
1
Justification:
According to ECHA Guidance (default)
AF for interspecies differences (allometric scaling):
1
Justification:
Although the LLNA is performed in the mouse, it recognised that there is no allometric scaling necessary for skin sensitization values in this type of studies.
AF for other interspecies differences:
1
Justification:
According to ECHA Guidance (default)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance (default)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2. Nevertheless, the Source substance being so closely related to all the constituents of the Target Substance, and presenting identical or worst case profiler categories relevant for skin sensitisation, it is deemed unnecessary to add an assessment factor in this case.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.725 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
300
Dose descriptor starting point:
LOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
218 mg/m³
Explanation for the modification of the dose descriptor starting point:

As there was no reproductive or developmental effect observed up to the highest dose tested (OECD 414), the LOAEL for repeated dose toxicity (OECD 408) where systemic toxicity was observed was used to derive the Long-term systemic DNEL.

AF for dose response relationship:
3
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance (default).

The default calculator is malfunctioning and does not allow to chose the LOAEL for repeated dose toxicity.

As there was no reproductive or developmental effect observed up to the highest dose tested (OECD 414), the LOAEL for repeated dose toxicity (OECD 408) where systemic toxicity was observed was used to derive the Long-term systemic DNEL.

AF for dose response relationship:
3
Justification:
Default (DNEL calculator). Starting point is a LOAEL.
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
45 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
other: NESIL derived from EC3 = 3.6%
Value:
900 µg/m³
AF for dose response relationship:
1
Justification:
According to ECHA Guidance (default)
AF for differences in duration of exposure:
1
Justification:
According to ECHA Guidance (default)
AF for interspecies differences (allometric scaling):
1
Justification:
Although the LLNA is performed in the mouse, it recognised that there is no allometric scaling necessary for skin sensitization values in this type of studies.
AF for other interspecies differences:
1
Justification:
According to ECHA Guidance (default)
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance (default)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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:
0.42 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance (default).

The default calculator is malfunctioning and does not allow to chose the LOAEL for repeated dose toxicity.

As there was no reproductive or developmental effect observed up to the highest dose tested (OECD 414), the LOAEL for repeated dose toxicity (OECD 408) where systemic toxicity was observed was used to derive the Long-term systemic DNEL.

AF for dose response relationship:
3
Justification:
Default (DNEL calculator). Starting point is a LOAEL.
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
According to ECHA Guidance (default), as a read-across study was used for the DNEL derivation the default assessment factor should be 2.
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population