Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
11.76 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 (mg/kg)*1/0.38*6.7/10*0.5 = 882 mg/m3

AF for dose response relationship:
1
Justification:
Standard AF acccording to ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic, standard AF according to ECHA guidance document
Justification:
Already taken into consideration during allometric scaling
AF for intraspecies differences:
5
Justification:
Standard AF acccording to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Standard AF acccording to ECHA guidance document
AF for remaining uncertainties:
2.5
Justification:
Standard AF acccording to ECHA guidance document
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:
3.33 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
5
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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

Not classified as a hazard for the eyes

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 * 1/1.15*0.5 = 435 mg/m3

AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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:
1.6 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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:
1.6 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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

Not classified as a hazard to the eye.