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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
21.3 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):
25
Dose descriptor starting point:
NOAEL
Value:
302 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
532 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long term toxicity studies via the inhalation route are available for the test substance. Route-to-route extrapolation is performed.

The NOAEL (oral route) observed in the 90 -day repeated dose toxicity study (Weisz, 2018) was used to derive a DNEL long-term, systemic effects via the inhalation route. This study was performed according to the OECD guideline 408 and in compliance with GLP. The NOAEL was considered to be 302 mg/kg bw/day. After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point is 532.47 mg/m3 = 302 mg/kg bw/day x 1/0.38 m3/kg bw/d x 6.7 m3/10m3. The oral dose for rats was converted to corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 hours exposure of 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 the respective conditions (6.7 m3 for base level, 10m3 for light activity). In addition, there was no additional correction factor as the bioavailability via the inhalation route and via the oral route are considered to be 50%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point, no additional assessment factor is required.
AF for differences in duration of exposure:
2
Justification:
difference in duration, subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already in the route to route extrapolation correction
AF for other interspecies differences:
2.5
Justification:
Remaining differences between species, default assessment factor
AF for intraspecies differences:
5
Justification:
ECHA default value for worker population
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.1 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
Dose descriptor starting point:
NOAEL
Value:
302 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 510 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term dermal toxicity studies are available for the test substance. Route-to-route extrapolation is performed. The NOAEL (oral route) observed in the 90 -day repeated dose toxicity study (Weisz, 2018) was used to derive a DNEL long-term, systemic effects via the dermal route. This study was performed according to the OECD guideline 408 and in compliance with GLP. The NOAEL was considered to be 302 mg/kg bw/day. After route-to-route extrapolation (oral to dermal) the dose descriptor starting point is 1510 mg/kg bw/day, as an additional correction factor of 5 is added. The bioavailability after oral exposure is assumed to be 50% and the bioavailability after dermal exposure is assumed to be only 10%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point, no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
difference in duration, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default value for systemic toxicity, rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining differences between species
AF for intraspecies differences:
5
Justification:
ECHA default value for worker population
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

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:
5.25 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):
50
Dose descriptor starting point:
NOAEL
Value:
302 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
262.61 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long-term toxicity studies via the inhalation route are available for the test substance. Route-to-route extrapolation is performed.

The NOAEL (oral route observed in the 90 -day repeated dose toxicity study (Weisz, 2018) was used to derive a DNEL long-term, systemic effects via the inhalation route. This study was performed according to OECD guideline 408 and in compliance with GLP. The NOAEL was considered to be 302 mg/kg bw/day. After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point is 262.61 mg/m3 = 302 mg/kg bw/day x 1/1.15 m3/kg bw/day. The oral dose for rats was converted to corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure of general population). There was no additional correction factor for differences in bioavailability as the bioavailability via the inhalation route and via the oral route are considered to be 50%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point, no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
difference in duration, subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already in the route to route extrapolation correction
AF for other interspecies differences:
2.5
Justification:
Remaining differences between species, default assessment factor
AF for intraspecies differences:
10
Justification:
ECHA default value for general population
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.55 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):
200
Dose descriptor starting point:
NOAEL
Value:
302 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 510 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term dermal toxicity studies are available for the test substance. Route-to-route extrapolation is performed. The NOAEL (oral route) observed in the 90 -day repeated dose toxicity study (Weisz, 2018) was used to derive a DNEL long-term, systemic effects via the dermal route. This study was performed according to the OECD guideline 408 and in compliance with GLP. The NOAEL was considered to be 302 mg/kg bw/day. After route-to-route extrapolation (oral to dermal) the dose descriptor starting point is 1510 mg/kg bw/day, as an additional correction factor of 5 is added. The bioavailability after oral exposure is assumed to be 50% and the bioavailability after dermal exposure is assumed to be only 10%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point, no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
difference in duration, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Default value for systemic toxicity, rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining differences between species
AF for intraspecies differences:
10
Justification:
ECHA default value for general population
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.51 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):
200
Dose descriptor starting point:
NOAEL
Value:
302 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A key, 90 -day repeated dose toxicity study was performed according to the OECD guideline 408 and in compliance with GLP (Weisz, 2018). No route-to-route extrapolation is required. The NOAEL was considered to be 302 mg/kg bw/day and is the dose descriptor starting point used to derive DNEL.
AF for dose response relationship:
1
Justification:
NOAEL is used as starting point, no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
difference in duration, subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for systemic toxicity, rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining differences between species
AF for intraspecies differences:
10
Justification:
ECHA default value for general population
AF for the quality of the whole database:
1
Justification:
High quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
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