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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.031 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Dose descriptor starting point:
LOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
7.05 mg/m³
Explanation for the modification of the dose descriptor starting point:

The LOAEL of 4 mg/kg/day established in a developmental toxicity study in rats (subcutaneous route of administration, equivalent to OECD414; Gotz et al., 1983) was used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from subcutaneous to inhalation, the dose descriptor starting point is 7.06 mg/m3 = 4 mg/kg/day x 1/0.38 m3/kg/day x 0.67. The subcutaneous dose for rats was converted to the corresponding air concentration using a standard breathing volume for rats (0.38 m3/kg for 8 hours exposure for workers). For workers, the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under respective conditions (6.7 m3 for base level, 10 m3 for light activity). No correction factor is applied as the bioavailaiblity after subcutaneous administration is assumed to be similar as after inhalation exposure.

AF for dose response relationship:
3
Justification:
LOAEL is used as starting point
AF for differences in duration of exposure:
6
Justification:
subacute to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
included in route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
no need for further assessment factor
AF for remaining uncertainties:
1
Justification:
no need for further assessment factor
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:
8.88 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
900
Dose descriptor starting point:
LOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LOAEL of 4 mg/kg/day established in a developmental toxicity study in rats (subcutaneous route of administration, equivalent to OECD414; Gotz et al., 1983) was used to derive a DNEL long-term, systemic effects via dermal administration. After route-to-route extrapolation (subcutaneous to dermal) the dose descriptor starting point is 8 mg/kg/day= 4 mg/kg/day x 2. A correction factor of 2 is applied as the bioavailability after subcutaneous administration is assumed to be 100% while it is assumed to be 50% after dermal exposure.

AF for dose response relationship:
3
Justification:
LOAEL is the starting point
AF for differences in duration of exposure:
6
Justification:
subacute to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
no need for further assessment factor
AF for remaining uncertainties:
1
Justification:
no need for further assessment factor
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:
0.008 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Dose descriptor starting point:
LOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
3.48 mg/m³
Explanation for the modification of the dose descriptor starting point:

The LOAEL of 4 mg/kg/day established in a developmental toxicity study in rats (subcutaneous route of administration, equivalent to OECD414; Gotz et al, 1983) was used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from subcutaneous to inhalation, the dose descriptor starting point LOAEC is 3.48 mg/m³ = 4 mg/kg/day x 1/1.15 m³/kg/day. The subcutaneous dose for rats was converted to the corresponding air concentration using a standard breathing volume for rats (1.15 m³/kg for 24 hours exposure of general public). No correction factor of 2 is applied as the bioavailaiblity after subcutaneous administration is assumed to be 100% and similar to the bioavailability after inhalation.

AF for dose response relationship:
3
Justification:
LOAEL is used as starting point
AF for differences in duration of exposure:
6
Justification:
subacute to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
included in route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no need for further assessment factor
AF for remaining uncertainties:
1
Justification:
no need for further assessment factor
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:
4.44 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LOAEL of 4 mg/kg/day established in a developmental toxicity study (subcutaneous route of administration, equivalent to OECD414; Gotz et al, 1983) was used to derive a DNEL long-term, systemic effects via dermal administration. After route-to-route extrapolation (subcutaneous to dermal) the dose descriptor starting point is 8 mg/kg/day= 4 mg/kg/day x 2. A correction factor of 2 is applied as the bioavailaiblity after subcutaneous administration is assumed to be 100% and after dermal exposure 50%.

AF for dose response relationship:
3
Justification:
LOAEL is used as starting point
AF for differences in duration of exposure:
6
Justification:
subacute to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no need for further assessment factor
AF for remaining uncertainties:
1
Justification:
no need for further assessment factor
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:
4.44 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LOAEL of 4 mg/kg/day established in a developmental toxicity study in rats (subcutaneous route of administration, OECD414; Gotz et al, 1983) was used to derive a DNEL long-term, systemic effects for oral route. After route-to-route extrapolation (subcutaneous to oral) the dose descriptor starting point is 8 mg/kg/day = 4 mg/kg/day x 2.

The bioavailaibility after subcutaneous exposure is assumed to be 100% and after oral exposure 50%.

AF for dose response relationship:
3
Justification:
LOAEL was used as starting point
AF for differences in duration of exposure:
6
Justification:
subacute to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no need for further assessment factor
AF for remaining uncertainties:
1
Justification:
no need for further assessment factor
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

No consumer use is foreseen for this substance. However, as exposure for humans via the environment via inhalation, dermal and oral route is considered as relevant for this substance, DNELs were derived for the general population.