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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
62.4 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
18 725 mg/m³
Explanation for the modification of the dose descriptor starting point:
An inhalation study is nor available because substance has a high melting point and a very low vapour pressure and exposure by inhalation will be negligible.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
The substance has a high melting point and a very low vapour pressure and exposure by inhalation will be negligible.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.9 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
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long term dermal study available.
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value.
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Acute dermal study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Correction for metabolic rate default value
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic exposure default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
5
Justification:
Worker default value
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A single application of the test material to the non-irrigated eye of 6 rabbits produced no corneal opacity or iritis and minimal conjunctival irritation. All treated eyes appeared normal at the 72 -hour observation. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.2 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
18 725 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation study not available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.46 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
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Very few substances show higher toxicity by dermal contact than oral therefore the oral study was used as the starting point:
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
dermal study available
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.11 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
240
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub-chronic to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value.
AF for other interspecies differences:
1
Justification:
Default 1:1 extrapolation for oral to dermal
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.46 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
Modified dose descriptor starting point:
NOAEL
Value:
2 675 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for differences in duration of exposure:
6
Justification:
Sub acute to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
5 000
AF for dose response relationship:
1
Justification:
Dose response regarded as reliable
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human default value
AF for other interspecies differences:
2.5
Justification:
Default value for correction to metabolic rate value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value; database regarded as reliable
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population