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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.35 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:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.25 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data are available for the inhalation route therefore the NOAEL resulted from a repeated dose study via oral route is used.

Route-to-route extrapolation is therefore needed from the oral to the inhalation route.

The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to workers (10 m3in 8h and light activity), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance. It is assumed that absorption rate via inhalation route is 100 % instead the one via oral route is 50 %.

NOAELoral= 30 mg/kg b.w

Standard human body weight = 70 kg

Default human breathing volume for workers in 8 hours = 10 m3

Therefore, NOAECinh= (30/4)* (70/10) * 50 %= 26.25 mg/m3

AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for interspecies remaining differences
AF for intraspecies differences:
5
Justification:
Standard factor for worker
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
0.14 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:
30
Modified dose descriptor starting point:
NOAEL
Value:
42 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation needed. It is assumed that dermal absorption will not be higher than oral absorption; default factor is 1. Due to the difference between human (workers) and experimental exposure conditions, a correction factor of 1.4 is applied.

Therefore, the NOAEL = 30 mg/kg bw/day * 1.4 = 42 mg/m3

AF for dose response relationship:
1
Justification:
NOAEL used as a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard allometric factor for interspecies differences Rat vs Human
AF for other interspecies differences:
2.5
Justification:
Standard factor for interspecies remaining differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
low 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:
0.088 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:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13.13 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data are available for the inhalation route therefore the NOAEL resulted from a repeated dose study via oral route is used.

Route-to-route extrapolation is therefore needed from the oral to the inhalation route. The NOAEL rat is converted to NOAEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing by the default human breathing volume referring to general public (20 m3in 24 hours and basal caloric demand), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance. It is assumed that absorption rate via inhalation route is 100 % instead the one via oral route is 50 %.

NOAELoral= 30 mg/kg b.w

Standard human body weight = 70 kg

Default human breathing volume for general pobulation in 24 hours = 20 m3

Allometric scalling factor for rats as compared to humans = 4

Therefore, NOAECinh= (30/4)* (70/20) *50 %= 13.13 mg/m3

AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for interspecies remaining differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.05 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:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation needed. It is assumed that dermal absorption will not be higher than oral absorption; default factor is 1

AF for dose response relationship:
1
Justification:
NOAEL used as a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard allometric factor for interspecies differences Rat vs Human
AF for other interspecies differences:
2.5
Justification:
Standard factor for interspecies remaining differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
0.05 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:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL resulted from a repeated dose study via oral route is used.

AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for rat studies
AF for other interspecies differences:
2.5
Justification:
Standard factor for interspecies remaining differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population