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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.035 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):
75
Dose descriptor starting point:
NOAEC
Value:
3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2.64 mg/m³
Explanation for the modification of the dose descriptor starting point:

The dose descriptor starting point: NOAEL oral 28 day = 3 mg/kg bw/daCorrected inhalatory NOAEC = NOAEL * 1/0.38 m3/kg bw d * ABSoral rat/ABSinh human * 6.7 m3/ 10 m3 = 5.28 mg/m3 * ABSoral rat / ABSinh human "Assumed absorption via inhalation is twice absorption via oral" = 2.64 mg / m3.

AF for dose response relationship:
1
Justification:
default factor for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Taken into account in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
No indication for remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
600 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
600 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling rat
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
5
Justification:
workers population
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
2
Justification:
Limited number of endpoints have been examined in the acute toxicity study: only mortality

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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.01 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):
300
Dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral route to dermal route extrapolation was performed.
AF for dose response relationship:
1
Justification:
default factor for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
no indication for remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.11 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
LOAEL
Value:
316 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LD50 in that study was determined at 756 mg/kg bw, the LOAEL 316 mg/kg bw. The LOAEL was selected as startpoint.

AF for dose response relationship:
3
Justification:
LOEAL used as dose descriptor
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
No indication for remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
0.009 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):
150
Dose descriptor starting point:
NOAEC
Value:
3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point: NOAEL oral 28 day = 3 mg/kg bw/day. Corrected inhalatory NOAEC = NOAEL * 1/1.15 m3/kg bw d * ABSoral rat/ABSinh human = 2.61 mg/m3 * ABSoral rat / ABSinh human "Assumed absorption via inhalation is twice absorption via oral" = 1.30 mg / m3
AF for dose response relationship:
1
Justification:
default factor for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Taken into account in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default factor for the general population
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
no indication for remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEC
Value:
600 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
Limited number of endpoints have been examined in the acute toxicity study: only mortality

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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.005 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):
600
Dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral route to dermal route extrapolation
AF for dose response relationship:
1
Justification:
default factor for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default factor for the general population
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
no indication for remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.05 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL
Value:
316 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LD50 in that study was determined at 756 mg/kg bw, the LOAEL 316 mg/kg bw. The LOAEL was selected as startpoint.

AF for dose response relationship:
3
Justification:
LOAEL was used as dose descriptor
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
Justification:
default factor for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.005 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):
600
Dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route to route extrapolation
AF for dose response relationship:
1
Justification:
default AF for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining interspecies differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
Justification:
default AF for good quality of the database, taking into account completeness, consistency and the standard information requirements
AF for remaining uncertainties:
1
Justification:
no indication for remaining differences
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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:
50 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL (from repeated dose study, consequently conservative value)
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
Justification:
default AF for good quality of the database, taking into account completeness, consistency and the standard information requirements. 2 acute and 3 repeated dose toxicity tests were evaluated
AF for remaining uncertainties:
1
Justification:
Sublethal endpoints were taken into consideration

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population