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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4.2 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:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
52.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

The critical Point of Departure used to derive the DNEL is the NOAEL for maternal toxicity of 30 mg/kg bw/day

Oral

identified in the prenatal developmental toxicity study in rats exposed orally. Modification of the starting dose descriptor

was performed according to ECHA guidance

identified in the prenatal developmental toxicity study in rats exposed orally.

AF for dose response relationship:
1
Justification:
ECHA-Default according to R8 ECHA 2010
AF for differences in duration of exposure:
1
Justification:
ECHA-Default according to R8 ECHA 2010
AF for interspecies differences (allometric scaling):
1
Justification:
A factor of 4 is included in the determination of NOAEC(human) accordimg to Reach guidance R8.2
AF for other interspecies differences:
2.5
Justification:
ECHA-Default according to R8 ECHA 2010
AF for intraspecies differences:
5
Justification:
ECHA-Default according to R8 ECHA 2010
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A dermal subchronic study is available
AF for dose response relationship:
1
Justification:
ECHA-Default according to R8 ECHA 2010
AF for differences in duration of exposure:
2
Justification:
ECHA-Default according to R8 ECHA 2010
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA-Default according to R8 ECHA 2010
AF for other interspecies differences:
2.5
Justification:
ECHA-Default according to R8 ECHA 2010
AF for intraspecies differences:
5
Justification:
ECHA-Default according to R8 ECHA 2010
AF for the quality of the whole database:
1
Justification:
ECHA-Default according to R8 ECHA 2010
AF for remaining uncertainties:
1
Justification:
ECHA-Default according to R8 ECHA 2010
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

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:
no hazard identified
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
no hazard identified

Additional information - General Population