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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.5 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:
51.9 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
64.05 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral 90-day repeated dose toxicity study available.

Corrected human NOAEL = 64,05 mg/m³ (51,9 x 1/0,38 x7/5 x50/100 x 6.7/10)

A correction has to be made for workers because of their exposure only being 5 days a week instead of 7 days a week, which is a factor 7/5.  

Bioavailability: animal experiment (oral) = 50% (default oral)

Bioavailability human route  = 100% (default inhalation)

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
default value ECHA
AF for interspecies differences (allometric scaling):
1
Justification:
not required
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
5
Justification:
default value ECHA
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
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

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:
0.45 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:
51.9 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
22.56 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral 90-day repeated dose toxicity study available.

Corrected human NOAEL = 22,56 mg/m³ (51,9 x 1/1,15 x 50/100)

Bioavailability: animal experiment (oral) = 50%

Bioavailability human route  = 100% (default inhalation)

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
default value ECHA
Justification:
not required
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
10
Justification:
default value ECHA
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
0.26 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:
51.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral 90-day repeated dose toxicity study available.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
default value ECHA
AF for interspecies differences (allometric scaling):
4
Justification:
default value ECHA
AF for other interspecies differences:
2.5
Justification:
default value ECHA
AF for intraspecies differences:
10
Justification:
default value ECHA
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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