Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
372.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: REACH guidance and ECETOC 2010
Overall assessment factor (AF):
45
Modified dose descriptor starting point:
NOAEC
Value:
16 750 mg/m³
Explanation for the modification of the dose descriptor starting point:
In the absence of repeated dose inhalation toxicity data, the NOAEL from the 90 day repeated dose oral toxicity study in rat of Nolen (1981) (9,500 mg/kg bw/day) can be taken as a starting point for deriving a DNELlong-term, workers, inhalation. The value must first be corrected for route differences as described in REACH guidance document R.8 of May 2008 (‘Characterisation of dose (concentration) - response for human health’): NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) = (9,500 / 0.38) x (6.7/10) = 16,750 mg/m3.
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Already accounted for in oral to inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
Remaining differences
AF for intraspecies differences:
3
Justification:
Workers (according to ECETOC, 2010)
AF for the quality of the whole database:
3
Justification:
Assessment relies on data from substances representative of component of castor oil, dehydrated
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
52.78 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: REACH guidance and ECETOC, 2010
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
Value:
9 500 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining differences
AF for intraspecies differences:
3
Justification:
Workers
AF for the quality of the whole database:
3
Justification:
Assessment relies on data from substances representative of component of castor oil, dehydrated
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
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