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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.04 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:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176 mg/m³
Explanation for the modification of the dose descriptor starting point:
No repeated dose inhalation toxicity studies available; value derived from oral study.
AF for dose response relationship:
1
Justification:
Scientific judgment; justified in ECHA REACH guidance.
AF for differences in duration of exposure:
2
Justification:
Scientific judgment, duration does not increase toxicity, as judged by NOAEL of 100 mg/kg/day for 28 day oral toxicity study and 300 mg/kg/day for 90 day oral toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
Scientific judgment, justified in ECHA REACH guidance
AF for other interspecies differences:
2.5
Justification:
Scientific judgment, justified in ECHA REACH guidance
AF for intraspecies differences:
5
Justification:
Scientific judgment, justified in ECHA REACH guidance
AF for the quality of the whole database:
1
Justification:
Scientific judgment, justified in ECHA REACH guidance
AF for remaining uncertainties:
1
Justification:
Scientific judgment, justified in ECHA REACH guidance
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
1.74 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
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
86.96 mg/m³
Explanation for the modification of the dose descriptor starting point:
No repeated dose inhalation toxicity studies available; value derived from oral study.
AF for dose response relationship:
1
Justification:
Scientific judgment; ECHA REACH guidance
AF for differences in duration of exposure:
2
Justification:
Scientific judgment, duration does not increase toxicity, as judged by NOAEL of 100 mg/kg/day for 28 day oral toxicity study and 300 mg/kg/day for 90 day oral toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
Scientific judgment; ECHA REACH guidance
AF for other interspecies differences:
2.5
Justification:
Scientific judgment; ECHA REACH guidance
AF for intraspecies differences:
10
Justification:
Scientific judgment; ECHA REACH guidance
AF for the quality of the whole database:
1
Justification:
Scientific judgment; ECHA REACH guidance
AF for remaining uncertainties:
1
Justification:
Scientific judgment; ECHA REACH guidance
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Based on scientific judgment and guidance for ECHA REACH.