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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
29.6 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):
25
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
740 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr= NOAELoralx 1/0.38 [m3/kg/day] x ABSoral-rat/ABSinhal-humanx 6.7/10 [m3(8 h)] x fexpo-rat/fexpo-worker

NOAECcorr= 300 x 1/0.38 x 100%/100% x 6.7/10 x 7/5 [mg/m3]

NOAECcorr= 740 mg/m3

Factor

Value

Description

NOAELoral

300 mg/kg bw/day

No observed adverse effect level NOAEL (rat, m)

ABSora-rat

High

Oral absorption in the rat

ABSinhal-human

High

Inhalation absorption in humans

fexpo-rat

7 days/week

Exposure frequency rats

fexpo-worker

5 days/week

Exposure frequency worker

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value (subchronic to chronic extrapolation)
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in starting point derivation method; no further factor required
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Selected study is a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - 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):
100
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
420 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr= NOAELoralx ABSoral-rat/ABSdermal-humanx fexpo-rat/fexpo-worker

NOAELcorr= 300 x 100%/100% x 7/5 [mg/kg bw/day]

NOAELcorr= 420 mg/kg bw/day

Factor

Value

Description

NOAELoral

300 mg/kg bw/day

No observed adverse effect level NOAEL (rat, m)

ABSora-rat

High (100%)

Oral absorption in the rat

ABSdermal-human

High (100%)

Dermal absorption in humans

fexpo-rat

7 days/week

Exposure frequency rats

fexpo-worker

5 days/week

Exposure frequency worker

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value (subchronic to chronic extrapolation)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Selected study is a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
DNEL (Derived No Effect Level)
Value:
5.22 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):
50
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
261 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr= NOAELoralx 1/1.15 xABSoral-rat/ABSinhal-human

NOAECcorr= 300 x 1/1.15 x 100%/100% [mg/m3]

NOAECcorr= 261 mg/m3

Factor

Value

Description

NOAELoral

300 mg/kg bw/day

No observed adverse effect level NOAEL (rat, m)

ABSora-rat

High (100%)

Oral absorption in the rat

ABSinhal-human

High (100%)

Inhalation absorption in humans

fexpo-rat

7 days/week

Exposure frequency rats

fexpo-worker

5 days/week

Exposure frequency worker

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value (subchronic to chronic extrapolation)
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in starting point derivation method; no further factor required
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Selected study is a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAELcorr= NOAELoralxABSoral-rat/ABSdermal-human

NOAELcorr= 300 x 100%/100% [mg/kg bw/day]

NOAELcorr= 300 mg/m3

Factor

Value

Description

NOAELoral

300 mg/kg bw/day

No observed adverse effect level NOAEL (rat, m)

ABSora-rat

High (100%)

Oral absorption in the rat

ABSdermal-human

High (100%)

Dermal absorption in humans

fexpo-rat

7 days/week

Exposure frequency rats

fexpo-worker

5 days/week

Exposure frequency worker

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value (subchronic to chronic extrapolation)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Selected study is a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation required as the repeated dose toxicity study from which the NOAEL starting point was derived was performed using oral application.

AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default value (subchronic to chronic extrapolation)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Selected study is a reliable guideline study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population