Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.84 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation.
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.84 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for other interspecies differences:
1
Justification:
Not applicable for inhalation
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
85.5 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation.
AF for other interspecies differences:
2.5
Justification:
Not applicable for inhalation
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
85.5 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.94 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):
50
Dose descriptor starting point:
NOAEL
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
4
Justification:
Rat default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.94 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):
50
Dose descriptor starting point:
NOAEL
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to Human
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.85 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
Value:
85.51 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.85 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEC
Value:
85.51 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

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:
1.69 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation studies.
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.69 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation studies.
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
42.17 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation studies.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.22 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
42.17 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.97 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.97 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.43 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
NOAEC
Value:
42.17 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.43 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
42.17 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
AF for other interspecies differences:
1
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.97 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Screening reproductive toxicity test dosing has the same number of dosing days as the standard 28-Day test.
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.97 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
Value:
97 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
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:
Klimisch 1 study. Use of the default assessment factor since the starting point of the DNEL calculation was the NOAEL.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties exist.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population