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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.3 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:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalation study undertaken.

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:
280 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:
14 000 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalation study avalaible

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:
23.3 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:
280 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:
3.3 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No 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:
Oral
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:

No 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:
0.08 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:
No indication of irritation, therefore 1:1 extrapolation used.
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:
No indication of irritation, therefore 1:1 extrapolation used.
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.7 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
7 000 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 defualt 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/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:
14 000 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 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:
11.7 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 defualt 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:
140 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:
1.7 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal study returned a negative result. Only oral 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:
20 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:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal study returned a negative result. Only oral 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:
0.04 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:
Dermal toxicity study gave a negative reponse. Therefore a 1:1 extrapolation employed.
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/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:
Dermal toxicity study gave a negative reponse. Therefore a 1:1 extrapolation employed.
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:
1.7 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal study returned a negative result. Only oral 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:
20 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:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal study returned a negative result. Only oral 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.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population