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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
35 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):
100
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 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
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

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:
17.5 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):
200
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 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
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.062 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 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
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable as GLP compliant oral study used.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable as GLP compliant oral study used.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population