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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.5 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
Modified dose descriptor starting point:
NOAEC
Value:
187.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conservative default assumptions applied per REACH Information Requirements, Chapter R.8 (ECHA 2010) provide adequate protection against inhalation exposures

Note: NOAEL oral route = 375 mg/kg/day.

AF for dose response relationship:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for differences in duration of exposure:
2
Justification:
Sub-chronic-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for interspecies differences (allometric scaling):
1
Justification:
No need to apply factor for allometric scaling per REACH Information Requirements, Chapter R.8, Section R.8.4.2; Appendix R.8-2, Example B.3 (ECHA 2010)
AF for other interspecies differences:
2.5
Justification:
2.5 for remaining interspecies differences not accounted in allometric scaling (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for intraspecies differences:
5
Justification:
Default for worker exposures (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for the quality of the whole database:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for remaining uncertainties:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
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:
3.75 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:
375 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Conservative default assumptions applied per REACH Information Requirements, Chapter R.8 (ECHA 2010) provide adequate protection against dermal exposures
AF for dose response relationship:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for differences in duration of exposure:
2
Justification:
Sub-chronic-to-Chronic (Table R.8-5, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling of dog-to-human, 1.4 (AS factor for dog) x 2.5 for remaining differences (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for other interspecies differences:
2.5
Justification:
Allometric scaling of dog-to-human, 1.4 (AS factor for dog) x 2.5 for remaining differences (Tables R.8-4 and R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2012)
AF for intraspecies differences:
5
Justification:
Default for worker exposures (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for the quality of the whole database:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
AF for remaining uncertainties:
1
Justification:
Default (Table R.8-6, REACH Information Requirements, Chapter R.8, ECHA 2010)
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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