Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.165 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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
12.34 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr = NOAELoral * (1 / 0.38 m³/kg bw/day) * (ABSoral-rat / ABSinh-human) * (6.7 m³ (8h) / 10 m³ (8h)) * (7 days exposure rat / 5 exposure worker) = 10 mg/kg bw/day*(1 / 0.38 m³/kg bw/day)*(0.5 / 1)*0.67*1.4 = 12.34 mg/m³.

It is assumed that oral absorption rate is 50% of that of inhalation absorption.

ABSoral-rat = oral absorption rate in rats, ABSinh-human = inhalation absorption rate in humans.

AF for dose response relationship:
1
Justification:
ECHA default value: The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from subacute to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA default value (no allometric scaling needs to be applied for route-to-route extrapolation from the oral to the inhalation route).
AF for other interspecies differences:
2.5
Justification:
ECHA default value.
AF for intraspecies differences:
5
Justification:
ECHA default value for the worker.
AF for the quality of the whole database:
1
Justification:
DNEL calculation is based on a GLP guideline study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.47 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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
140 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr = NOAELoral * (ABSoral-rat / ABSdermal-human) * (7 day exposure rat / 5 days exposure worker) = 10 mg/kg bw/day * (100%/10%) * 1.4 = 140 mg/kg bw/day.

ABSoral-rat = oral absorption rate in rats, ABSdermal-human = dermal absorption rate in humans.

The test substance has a logPow of 5.814 and a calculated flux of 0.00394 µg/cm²/h (DERMWIN). According to Kroes et al. (Food Chem Toxicol 45, 2533–62, 2007) a dermal absorption rate of 10% can be assumed if the flux is below 0.1 µg/cm²/h. It is therefore assumed that the dermal absorption rate is 10% of the oral absorption rate.

AF for dose response relationship:
1
Justification:
ECHA default value: The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from subacute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default value for the rat.
AF for other interspecies differences:
2.5
Justification:
ECHA default value.
AF for intraspecies differences:
5
Justification:
ECHA default value for the worker.
AF for the quality of the whole database:
1
Justification:
DNEL calculation is based on a GLP guideline study.
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

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:
0.029 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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4.35 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr = NOAELoral * (1 / 1.15 m³/kg bw/day) * (ABSoral-ra t/ ABSinh-human) = 10 mg/kg bw/day * (1 / 1.15 m³/kg bw/day) * (0.5 / 1) * = 4.35 mg/m³.

It is assumed that oral absorption rate is 50% of that of inhalation absorption.

ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.

AF for dose response relationship:
1
Justification:
ECHA default value: The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from subacute to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA default value (no allometric scaling needs to be applied for route-to-route extrapolation from the oral to the inhalation route).
AF for other interspecies differences:
2.5
Justification:
ECHA default value.
AF for intraspecies differences:
10
Justification:
ECHA default value for the general population.
AF for the quality of the whole database:
1
Justification:
DNEL calculation is based on a GLP guideline study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr = NOAELoral * (ABSoral-rat / ABSdermal-human) = 10 mg/kg bw/day * (100% / 10%) = 100 mg/kg bw/day.

ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.

The test substance has a logPow of 5.814 and a calculated flux of 0.00394 µg/cm²/h (DERMWIN). According to Kroes et al. (Food Chem Toxicol 45, 2533–62, 2007) a dermal absorption rate of 10% can be assumed if the flux is below 0.1 µg/cm²/h. It is therefore assumed that the dermal absorption rate is 10% of the oral absorption rate.

AF for dose response relationship:
1
Justification:
ECHA default value: The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from subacute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default value for the rat.
AF for other interspecies differences:
2.5
Justification:
ECHA default value
AF for intraspecies differences:
10
Justification:
ECHA default value for the general population.
AF for the quality of the whole database:
1
Justification:
DNEL calculation is based on a GLP guideline study.
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.017 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:
10 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation required.

AF for dose response relationship:
1
Justification:
ECHA default value: The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from subacute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default value for the rat.
AF for other interspecies differences:
2.5
Justification:
ECHA default value
AF for intraspecies differences:
10
Justification:
ECHA default value for the general population.
AF for the quality of the whole database:
1
Justification:
DNEL calculation is based on a GLP guideline study.
AF for remaining uncertainties:
1
Justification:
No remaining 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:
no hazard identified

Additional information - General Population