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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.82 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:
750 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
661 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of dose descriptor starting point performed in accordance with Figure R.8-3 of Chapter R.8 using the following equation:-

Corrected Inhal (NOAEC) = Oral NOAEL * (1/0.38) * (ABSoral-rat/ ABSinh-human) * (6.7 / 10)

Corrected Inhal (NOEAC) = 750 * (1/0.38) * (50/100) * (6.7/10)

Corrected (NOAEC) = 661.18 mg/m3

AF for dose response relationship:
1
Justification:
A clear NOAEL was identified
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from sub-acute to chronic effects
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not applied for oral to inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default value for worker based interspecies differences.
AF for intraspecies differences:
5
Justification:
ECHA default value for worker based intraspecies differences.
AF for the quality of the whole database:
1
Justification:
High quality studies and database appropriate for the tonnage band.
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral absorption in the rat has been set to 50%, dermal absorption in humans has been set to 25%.

Corrected Dermal (NOAEL) = Oral NOAEL * (ABSoral-rat/ ABSinh-human)

Corrected Dermal (NOAEL) = Oral NOAEL * (50% oral absorption rat / 25% dermal absorption human)

Corrected Dermal (NOAEL) = 750 * (50/25)

Corrected Dermal (NOAEL) = 1500 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was identified
AF for differences in duration of exposure:
6
Justification:
ECHA default value for extrapolation from sub-acute to chronic effects
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default value for allometric scaling between rat and human
AF for other interspecies differences:
2.5
Justification:
ECHA default value for worker based interspecies differences.
AF for intraspecies differences:
5
Justification:
ECHA default value for worker based intraspecies differences.
AF for the quality of the whole database:
1
Justification:
High quality studies and database appropriate for the tonnage band.
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:
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
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:
no hazard identified
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

The substance is not available for use by the general population and in the absence of potential exposure it is considered unnecessary to derive DNELs for the general population.