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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.03 mg/m³
Most sensitive endpoint:
effect on fertility
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:
1.03 mg/m³
Value:
1.03 mg/m³
Explanation for the modification of the dose descriptor starting point:

A worker long-term inhalation DNEL was developed from the reproductive NOAEL of 350 mg/kg/day from the OECD 422 study.

The dose descriptor was corrected for an inhalation exposure with the factor of 0.38 m3/kg.

350 mg/kg /0.38 m3/kg = 921.05 mg/m3

This was further corrected for 50% oral bioavailability

921.05 mg/m3 /2 = 460.53 mg/m3

This was further corrected for light work with the value of 0.67

460.53* 0.67 = 308.55 mg/m3.

Finally, an adjustment factor of 300 was used. 5 for interspecies, 4 for allometric scaling, 2.5 for interspecies and 6 for subacute to chroic.

308.55 mg/m3  / 300 = 1.03 mg/m3

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
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:
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

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:
0.25 mg/m³
Most sensitive endpoint:
effect on fertility
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:
0.25 mg/m³
Value:
0.25 mg/m³
Explanation for the modification of the dose descriptor starting point:

A general population long-term inhalation DNEL was developed from the reproductive NOAEL of 350 mg/kg/day from the OECD 422 study.

The dose descriptor was corrected for an inhalation exposure with the factor of 1.15 m3/kg.

350 mg/kg / 1.15 m3/kg = 304.35 mg/m3

This was further corrected for 50% oral bioavailability

304.35 mg/m3 /2 = 152.17 mg/m3

Finally, an adjustment factor of 600 was used. 10 for interspecies, 4 for allometric scaling, 2.5 for interspecies and 6 for subacute to chroic.

152.17 mg/m3  / 600 = 0.25 mg/m3

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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:
DNEL (Derived No Effect Level)
Value:
0.58 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
0.58 mg/kg bw/day
Value:
0.58 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A general population long-term oral DNEL was developed from the reproductive NOAEL of 350 mg/kg/day from the OECD 422 study.

Finally, an adjustment factor of 600 was used. 10 for interspecies, 4 for allometric scaling, 2.5 for interspecies and 6 for subacute to chroic.

350 mg/kg  / 600 = 0.58 mg/kg

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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