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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
29 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):
240
Modified dose descriptor starting point:
NOAEC
Value:
1 750 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
5
Justification:
human to workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 111 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):
40
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
5
Justification:
human to worker

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:
8.3 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral to dermal
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
5
Justification:
human to workers
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

1     Workers

Summary according to ECHA Guidance R.8

Exposure pattern

DNEL

 

workers

inhalation, systemic, long-term

29 mg/m³

inhalation, systemic, acute

1,111 mg/m³

inhalation, local, long-term

no data available

inhalation, local, acute

no data available

dermal, systemic, long-term

8.3 mg/kg

dermal, systemic, acute

100 mg/kg

dermal, local, long-term

no data available

dermal, local, acute

no data available

Hazard for the eyes

no

"Units for local effects are mg/m³for inhalation; and for dermal exposure: mg/cm² skin, mg/person/day (e.g., calculated based on the deposited amount per cm² times the actually exposed body area), or a measure of concentration (% or ppm)"

1.1  inhalation, systemic, long-term

Start value: NOAEL (sub-acute) = 1,000 mg/kg bw/day

 

Uncertainties

AF

Justification

route of exposure

2

oral to inhalation

Interspecies differences

4

rat to human

Intraspecies differences

5

human to workers

Exposure duration

6

sub-acute to chronic

Overall

240

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of NOAEC according to guideline R.8:

NOAEC (worker) = (1,000 mg/kg*70 kg) / (4*10 m³) = 1,750 mg/m³

 

Calculation of DNEL by taking into account the remaining AFs:

DNEL (inhalation, systemic, long-term) = 1750 mg/m³/ 60 =29 mg/m³

1.2  inhalation, systemic, acute

Start value: NOAEL (acute) = 2,000 mg/kg bw since LD50(oral) > 2,000 mg/kg bw

Uncertainties

AF

Justification

route of exposure

2

oral to inhalation

Interspecies differences

4

rat to human

Intraspecies differences

5

human to worker

Overall

40

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of NOAEC according to guideline R.8:

NOAEC (worker) = (2,000 mg/kg*70 kg) / (4*10 m³) = 3,500 mg/m³

 

Calculation of DNEL (4 hours) by taking into account the remaining AFs:

3,500 mg/m³/ 10 = 350 mg/m³

 

Correction for short term exposure (15 min) using modification of Haber's Law (ECHA guideline R.7a):

c = ((350 mg/m³)³*(8.0 h / 0.25 h))1/3= 1,111 mg/m³

DNEL (inhalation, systemic, acute) =1,111 mg/m³

1.3  dermal, systemic, long-term

Start value: NOAEL (sub-acute) = 1,000 mg/kg bw/day

Uncertainties

AF

Justification

route of exposure

1

oral to dermal

Interspecies differences

4

rat to human

Intraspecies differences

5

human to workers

Exposure duration

6

sub-acute to chronic

Overall

120

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (dermal, systemic, long-term) = (1,000 mg/kg) / 120 =8.3 mg/kg

 

1.4  dermal, systemic, acute

Start value: NOAEL (acute) = 2,000 mg/kg bw since LD50(dermal) > 2,000 mg/kg bw

Uncertainties

AF

Justification

route of exposure

1

same route

Interspecies differences

4

rat to human

Intraspecies differences

5

human to worker

Overall

20

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (dermal, systemic, acute) = (2,000 mg/kg) / 20 =100 mg/kg

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22 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):
480
Modified dose descriptor starting point:
NOAEC
Value:
2 612 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human to general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
828 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):
80
Modified dose descriptor starting point:
NOAEC
Value:
5 223 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral to inhalation
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human to general population

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:
4.2 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral to dermal
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human to general population
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:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
same route
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human to general population

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:
4.2 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
same route
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human to general population
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

1     General population

Summary according to ECHA Guidance R.8

Exposure pattern

DNEL

 

general population

inhalation, systemic, long-term

22 mg/m³

inhalation, systemic, acute

828 mg/m³

inhalation, local, long-term

no data available

inhalation, local, acute

no data available

dermal, systemic, long-term

4.2 mg/kg

dermal, systemic, acute

50 mg/kg

dermal, local, long-term

no data available

dermal, local, acute

no data available

oral, systemic, long-term

4.2 mg/kg

oral, systemic, acute

50 mg/kg

Hazard for the eyes

no

Units for local effects are mg/m³for inhalation; and for dermal exposure: mg/cm²skin, mg/person/day (e.g., calculated based on the deposited amount per cm² times the actually exposed body area), or a measure of concentration (% or ppm).

1.1  inhalation, systemic, long-term

Start value: NOAEL (sub-acute) = 1,000 mg/kg bw/day

 

Uncertainties

AF

Justification

route of exposure

2

oral to inhalation

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Exposure duration

6

sub-acute to chronic

Overall

480

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of NOAEC according to guideline R.8:

NOAEC (worker) = (1,000 mg/kg*70 kg) / (4*6.7 m³) = 2,612 mg/m³

 

Calculation of DNEL by taking into account the remaining AFs:

DNEL (inhalation, systemic, long-term) = 2612 mg/m³/ 120 =22 mg/m³

1.2  inhalation, systemic, acute

Start value: NOAEL (acute) = 2000 mg/kg bw since LD50(oral) > 2000 mg/kg bw

Uncertainties

AF

Justification

route of exposure

2

oral to inhalation

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Overall

80

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of NOAEC according to guideline R.8:

NOAEC (worker) = (2,000 mg/kg·70 kg) / (4*6.7 m³) = 5,223 mg/m3

 

Calculation of DNEL (4 hours) by taking into account the remaining AFs:

5,223 mg/m³/ 20 = 261 mg/m³

 

Correction for short term exposure (15 min) using modification of Haber's Law (ECHA guideline R.7a):

c = ((261 mg/m³)*(8.0 h / 0.25 h))1/3= 828 mg/m³

DNEL (inhalation, systemic, acute) =828 mg/m³

1.3  dermal, systemic, long-term

Start value: NOAEL (sub-acute) = 1,000 mg/kg bw/day

Uncertainties

AF

Justification

route of exposure

1

oral to dermal

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Exposure duration

6

sub-acute to chronic

Overall

240

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (dermal, systemic, long-term) = (1,000 mg/kg) / 240 = 4.2 mg/kg

1.4  dermal, systemic, acute

Start value: NOAEL (acute) = 2,000 mg/kg bw since LD50(dermal) > 2,000 mg/kg bw

Uncertainties

AF

Justification

route of exposure

1

same route

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Overall

40

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (dermal, systemic, acute) = (2,000 mg/kg) / 40 =50 mg/kg

1.5  oral, systemic, long-term

Start value: NOAEL (sub-acute) = 1,000 mg/kg bw/day

Uncertainties

AF

Justification

route of exposure

1

same route

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Exposure duration

6

sub-acute to chronic

Overall

240

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (oral, systemic, long-term) = (1,000 mg/kg) / 240 = 4.2 mg/kg

1.6  oral, systemic, acute

Start value: NOAEL (acute) = 2,000 mg/kg bw since LD50(oral) > 2,000 mg/kg bw

Uncertainties

AF

Justification

route of exposure

1

same route

Interspecies differences

4

rat to human

Intraspecies differences

10

human to general population

Overall

40

 

AFs according to ECETOC Technical Report No. 110

 

Calculation of DNEL:

DNEL (oral, systemic, acute) = (2,000 mg/kg) / 40 =50 mg/kg