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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

ABSoral/ABSdermal = 10, or AF=0.1

an assessment factor from oral to dermal route is applied, due to the high molecular weight and the polarity of the substance, which lower the possibility of dermal absorption

AF for dose response relationship:
1
Justification:
A NOAEL was used as the starting point for the DNEL and there were no unusual doseresponse
issues (as described in Chapter R.8) resulting in a default factor of 1.
AF for differences in duration of exposure:
2
Justification:
The NOAEL study duration will be of 12 weeks. Chapter R.8 recommends a sub-chronic to
chronic AF of 2.
AF for interspecies differences (allometric scaling):
4
Justification:
For systemic effects, Chapter R.8 recommends a (rat-to-human) allometric scaling factor of
4.
AF for other interspecies differences:
2.5
Justification:
For systemic effects, Chapter R.8 recommends a factor of 2.5 to account for “remaining
differences”.
AF for intraspecies differences:
5
Justification:
Chapter R.8 recommends a factor of 5 for workers given that this subpopulation does not
cover very young, very old and very ill.
AF for the quality of the whole database:
1
Justification:
The value will be based on a new GLP study on the registering substance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

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:
DNEL (Derived No Effect Level)
Value:
15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

NOAEL (repeated dose)= 300 mg/kg bw /day

ABSoral /ABS dermal = 0.1, since the dermal absorption is considered very low due to the phys-chem properties of the substance.

Therefore DNEL dermal = DNEL oral x 10

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
AF for dose response relationship:
1
Justification:
A NOAEL was used as the starting point for the DNEL and there were no unusual doseresponse
issues (as described in Chapter R.8) resulting in a default factor of 1.
AF for differences in duration of exposure:
2
Justification:
The NOAEL study duration will be of 12 weeks. Chapter R.8 recommends a sub-chronic to
chronic AF of 2.
AF for interspecies differences (allometric scaling):
4
Justification:
For systemic effects, Chapter R.8 recommends a (rat-to-human) allometric scaling factor of
4.
AF for other interspecies differences:
2.5
Justification:
For systemic effects, Chapter R.8 recommends a factor of 2.5 to account for “remaining
differences”.
AF for intraspecies differences:
10
Justification:
Chapter R.8 recommends a factor of 10 for general population
AF for the quality of the whole database:
1
Justification:
The value will be based on a new GLP study on the registering substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population