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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
49 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
36
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The corrected inhalatory NOAEC is obtained by multiplying (allometric scaling) the NOAEL with 1/0.38 m³/kg/day * 6.7 m³ / 10 m³ as 1763 mg/m³ .

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
chronic to subacute extrabolation according to guidance
AF for interspecies differences (allometric scaling):
3
Justification:
based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
AF for other interspecies differences:
1
Justification:
based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
see explanation below
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
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:
42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see explanation below

AF for dose response relationship:
1
Justification:
see explanation below
AF for differences in duration of exposure:
2
Justification:
see explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
see explanation below
AF for other interspecies differences:
1
Justification:
see explanation below1000
AF for intraspecies differences:
3
Justification:
see explanation below
AF for the quality of the whole database:
1
Justification:
see explanation below
AF for remaining uncertainties:
1
Justification:
see explanation below
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:
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

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:
25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
See explanation below
AF for differences in duration of exposure:
2
Justification:
See explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
See explanation below
AF for other interspecies differences:
1
Justification:
See explanation below
AF for intraspecies differences:
5
Justification:
See explanation below
AF for the quality of the whole database:
1
Justification:
See explanation below
AF for remaining uncertainties:
1
Justification:
See explanation below
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:
25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See explanation below
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
See explanation below
AF for differences in duration of exposure:
2
Justification:
See explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
See explanation below
AF for other interspecies differences:
1
Justification:
See explanation below
AF for intraspecies differences:
5
Justification:
See explanation below
AF for the quality of the whole database:
1
Justification:
See explanation below
AF for remaining uncertainties:
1
Justification:
See explanation below
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