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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.4 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):
75
Modified dose descriptor starting point:
LOAEC
Value:
105 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification to LOAEL workers: 6hr exposure rat vs 8 hr worker = 6/8 = 0.75 Respiratory volume rat vs human  = 6.7/10 = 0.67 Change ppm to mg/m3 = ppm x MW/24.45 = 50 x 102.13/24.45 = 209 mg/m3  Therefore modified LOAEL workers = 209 x 0.75 x 0.67 = 105 mg/m3

AF for dose response relationship:
3
Justification:
Using LOAEL instead of NOAEL (ECHA default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
1
Justification:
Inhaled rat to inhaled human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat dermal 90-day study = 100 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
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:
0.25 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):
150
Modified dose descriptor starting point:
LOAEC
Value:
37 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification to LOAEL general population: 6 hr exposure rat vs 24 hr general population       = 4 5 day exposure rat vs 7 day general population       = 5/7 = 0.714 Change ppm to mg/m3 = ppm x MW/24.45 = 50 x 102.13/24.45 = 209 mg/m3  Therefore modified LOAEL general population = 209 x 0.714/4 = 37 mg/m3

AF for dose response relationship:
3
Justification:
Using LOAEL instead of NOAEL (ECHA default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
1
Justification:
Inhaled rat to inhaled human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.5 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
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat dermal 90-day study = 100 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Oral rat to dermal human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.175 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
Modified dose descriptor starting point:
NOAEL
Value:
35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat oral 90-day study = 35 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Oral rat to oral human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remianing uncertainties (ECHA default)
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