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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
11.75 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
881.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat dermal NOAEL was converted into human inhalatory NOAEC considering: the "8h exposure rat standard Respiratory Volume" (0.38 m3/kg); the "rat dermal absorption"/"human inhalatory absorption" ratio (50/100); the "8h human standard Respiratory Volume"/"8h worker  Respiratory volume" ratio (6.7 m3/10 m3).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEC (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for differences in duration of exposure:
6
Justification:
Duration is extrapolated from sub-acute (28 days) to chronic (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for interspecies differences (allometric scaling):
1
Justification:
no Allometric scaling factor is used when setting an inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2, december 2010
AF for intraspecies differences:
5
Justification:
As mentioned in ECHA Guidance R8 v2, 2010: "For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 410 and GLP (Klimisch code 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:
1.67 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat dermal NOAEL was converted into human dermal NOAEL considering the "rat dermal absorption"/"human dermal absorption" ratio (50/100).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for differences in duration of exposure:
6
Justification:
Duration is extrapolated from sub-acute (28 days) to chronic (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is presented in ECHA Guidance R8 v2, december 2010.
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2, december 2010
AF for intraspecies differences:
5
Justification:
As mentioned in ECHA Guidance R8 v2, 2010: "For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 410 and GLP (Klimisch code 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

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:
2.9 mg/m³
Most sensitive endpoint:
repeated dose 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:
NOAEC
Value:
434.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat dermal NOAEL was converted into human inhalatory NOAEC considering: the "24h exposure rat standard Respiratory Volume" (1.15 m3/kg); the "rat dermal absorption"/"human inhalatory absorption" ratio (50/100).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for differences in duration of exposure:
6
Justification:
Duration is extrapolated from sub-acute (28 days) to chronic (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for interspecies differences (allometric scaling):
1
Justification:
Allomatric scaling is not applicable when setting an inhalation DNEL based on an inhalation animal study (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2, december 2010
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2, 2010: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 410 and GLP (Klimisch code 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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat dermal NOAEL was converted into human dermal NOAEL considering the "rat dermal absorption"/"human dermal absorption" ratio (50/100).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for differences in duration of exposure:
6
Justification:
Duration is extrapolated from sub-acute (28 days) to chronic (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is presented in ECHA Guidance R8 v2, december 2010.
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2, december 2010
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2, 2010: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 410 and GLP (Klimisch code 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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat dermal NOAEL was converted into human oral NOAEL considering the "rat dermal absorption"/"human oral absorption" ratio (50/100).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for differences in duration of exposure:
6
Justification:
Duration is extrapolated from sub-acute (28 days) to chronic (as mentioned in ECHA Guidance R8 v2, december 2010).
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is presented in ECHA Guidance R8 v2, december 2010.
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2, december 2010
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2, 2010: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 410 and GLP (Klimisch code 1)
AF for remaining uncertainties:
1
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