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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14.46 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):
37.5
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.37 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
36.14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
108.43 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.1 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):
150
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.3 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):
50
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.25 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.75 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEC
Value:
542 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Classified as irritating to skin according to the criteria of directive 67/548/EEC and category 2 according to CLP regulation (EC) n°1272/2008.

However, this was at neat (100%) concentration and was fully reversible within 14 days.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.57 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:
615 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.7 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):
30
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.91 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.74 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.05 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:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.15 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):
100
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.13 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.38 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
267 mg/m³
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.05 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:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for differences in duration of exposure:
3
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.15 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):
100
Dose descriptor starting point:
NOAEL
Value:
615 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for interspecies differences (allometric scaling):
4
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for other interspecies differences:
2.5
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for intraspecies differences:
10
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for the quality of the whole database:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors
AF for remaining uncertainties:
1
Justification:
Standard ECHA REACH Guidance Assessment Factors

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Classified as irritating to skin according to the criteria of directive 67/548/EEC and category 2 according to CLP regulation (EC) n°1272/2008.

However, this was at neat (100%) concentration and was fully reversible within 14 days.

Concentration for general (concumer) population, the concentration will be below 1%, therefore no hazard is associated for general use levels based on the in vivo skin irritation data.