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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
13.8 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:
280 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
346 mg/m³
Explanation for the modification of the dose descriptor starting point:

There are no adequate experimental data on the inhalation route available. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAECcorr. is calculated as follows:


- standard respiratory volume rat = 0.38 m³/kg/8h


- standard respiratory volume human = 6.7 m³/8h


- worker respiratory volume = 10 m³/8h


- absorption (oral, rat) = 50 % (default)


- absorption (inhalative, human) = 100 % (default)


--> modified dose descriptor (corrected inhalatory NOAEC) = 280 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (0.5/1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 346 mg/m³

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.6 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:
280 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 960 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There are no experimental data on repeated exposure by the dermal route available. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAELcorr. is calculated as follows:


- absorption (oral, rat) = 50 % (default)


- absorption (dermal, human) = 10 % (assumed as worst case)


--> modified dose descriptor (corrected dermal NOAEL) = 280 mg/kg bw/day * (0.5/0.1) * (7 exposure days/week; rat/5 exposure days/week; worker) = 1960 mg/kg bw/day

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance (rat --> human)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
2.4 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):
50
Dose descriptor starting point:
NOAEL
Value:
280 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
122 mg/m³
Explanation for the modification of the dose descriptor starting point:

There are no adequate experimental data on the inhalation route available. Therefore, the general population-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAECcorr. is calculated as follows:


- standard respiratory volume rat = 1.15 m³/kg/24h


- absorption (oral, rat) = 50 % (default)


- absorption (inhalative, human) = 100 % (default)


--> modified dose descriptor (corrected inhalatory NOAEC) = 280 mg/kg bw/day * (1/1.15 m³/kg/d) * (0.5/1) = 122 mg/m³

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
200
Dose descriptor starting point:
NOAEL
Value:
280 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There are no experimental data on repeated exposure by the dermal route available. Therefore, the general population-DNEL long-term for dermal route - systemic is derived from the NOAEL of 280 mg/kg bw/day, obtained in the key subchronic oral repeated dose study in Wistar rats. The NOAELcorr. is calculated as follows:


- absorption (oral, rat) = 50 % (default)


- absorption (dermal, human) = 10 % (assumed as worst case)


--> modified dose descriptor (corrected dermal NOAEL) = 280 mg/kg bw/day * (0.5/0.1) = 1400 mg/kg bw/day

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance (rat --> human)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
1.4 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:
280 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance (subchronic --> chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance (rat -->human)
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population