Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
50.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
5 040 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
2 532.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC (corrected) adjusted according to ECHA guidance:


NOAEC (corrected) = NOAEC * 6/8 h * 6.7/10 m³

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for remaining interspecies differences according to ECHA Guideline
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences according to ECHA Guideline
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:
7.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
5 040 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
1 451.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 0,384 m³/kg bw/d = 1451.5 mg/kg bw/d


with correction for exposure regime = 6/8 h/d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to ECHA Guideline
AF for interspecies differences (allometric scaling):
4
Justification:
AF for interspecies differences according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for other interspecies differences according to ECHA Guideline
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences according to according to ECHA Guideline
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Dermal
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)

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:
9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
5 040 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
900 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC corr = NOAEC * 6/24 h/d * 5/7 d


with 6/24 h/d * 5/7 d being the correction for exposure regime

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for other interspecies differences according to ECHA Guideline
AF for intraspecies differences:
10
Justification:
AF for intraspecies differences according to ECHA Guideline
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:
2.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEC
Value:
5 040 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
900 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 5/7 d* 0,384 m³/kg bw/d = 900 mg/kg bw/d


with correction for exposure regime = 6/8 h/d * 5/7 d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to ECHA Guideline
AF for interspecies differences (allometric scaling):
4
Justification:
AF for interspecies differences according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for other interspecies differences according to ECHA Guideline
AF for intraspecies differences:
10
Justification:
AF for intraspecies differences according to ECHA Guideline
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:
2.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEC
Value:
5 040
Modified dose descriptor starting point:
NOAEL
Value:
900 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 5/7 d* 0.384 m³/kg bw/d = 900 mg/kg bw/d


with correction for exposure regime = 6/8 h/d * 5/7 d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to ECHA Guideline
AF for interspecies differences (allometric scaling):
4
Justification:
AF for interspecies differences according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for other interspecies differences according to ECHA Guideline
AF for intraspecies differences:
10
Justification:
AF for intraspecies differences according to ECHA Guideline
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