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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.41 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:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
185 mg/m³
Explanation for the modification of the dose descriptor starting point:

As no long-term study via inhalation is available, route-to-route extrapolation has been performed. The NOAEL of 150 mg/kg bw/d observed in the oral repeated dose toxicity study was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 150 mg/kg bw/d x 1/(0.38 m³/kg/d) x 6.7 m³/10 m³ x 0.5 * (7d/5d) = 185 mg/m³. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (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 the respective conditions (6.7m³ for base level, 10m³ for light activity). In addition, the NOAEL needs to be divided by 2 as the bioavailability via the inhalation route is considered as 100% while for oral exposure this is only 50%. A correction factor 7/5 for difference in exposure duration and frequency was added (7 days/week dosing in the animal study, 5 days / week exposure of the workers).

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point; no additional assessment factor required
AF for differences in duration of exposure:
2
Justification:
Difference in duration, sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Covered by calculation for route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
default assessment factor
AF for remaining uncertainties:
1
Justification:
default 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:
2.1 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:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
210 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term dermal toxicity study is available for the test substance. However, data from an oral repeated dose toxicity study could be used after extrapolation to the dermal route. The modified NOAEL was considered 210 mg/kg b/d (150 mg/kg bw/d * 1 * (7d/5d) = 210 mg/kg bw/d). For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption.


A correction factor of 7/5 is applied to correct for difference in exposure duration and frequency (7 days / week for the animal study, 5 days/week for the workers).

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, sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
from rat to human
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
default assessment factor
AF for remaining uncertainties:
1
Justification:
default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
1.3 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):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
65 mg/m³
Explanation for the modification of the dose descriptor starting point:

As no long-term study via inhalation is available, route-to-route extrapolation has been performed. The NOAEL observed in the oral repeated dose toxicity study was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 150 mg/kg bw/d x (1/1.15 m³/kg bw/d) x 0.5= 65 mg/m³. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 hours exposure for general population). In addition, the NOAEL needs to be divided by 2 as the bioavailability via the inhalation route is considered as 100% while for oral exposure this is only 50%.

AF for dose response relationship:
1
Justification:
NOAEL is starting point, so no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
is included in the route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no additional factor required
AF for remaining uncertainties:
1
Justification:
no additional factor required
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:
0.75 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term dermal toxicity study is available for the test substance. However, data from an oral repeated dose toxicity study could be used after extrapolation to the dermal route. The NOAEL was considered 150 mg/kg b/d. For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption.

AF for dose response relationship:
1
Justification:
NOAEL is starting point, so no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no additional factor required
AF for remaining uncertainties:
1
Justification:
no additional factor required
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 150 mg/kg bw/d was established in an oral repeated dose toxicity study with the test substance (OECD 408). No modification of the dose descriptor starting point is required.

AF for dose response relationship:
1
Justification:
NOAEL is starting point, so no additional assessment factor is required
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default assessment factor
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
no additional factor required
AF for remaining uncertainties:
1
Justification:
no additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population