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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
336.75 mg/m³
DNEL related information
Overall assessment factor (AF):
25
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
47.75 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
100
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The long-term DNELs are based on a 90 -day oral feeding study performed in F344/N rats with Castor oil (CAS-No. 8001 -79 -4) as a Read Across substance. The NOAEL in this study was found to be greater than 5000 mg/kg bw/d (highest dose tested).

The molecular weight of Castor oil (CAS 8001 -79 -4) is 933.43.

The molecular weight of Castor oil, hydrogenated (CAS 8001 -78 -3) is 891.5.

With regard to the molecular weight ratio of both substances the NOAEL used for the calculation of DNELs was assumed to be 4775 mg/kg bw/d.

The assessment factors were chosen according to ECHA Guidance document R.8 (Characterisation of dose [concentration]-response for human health, May 2008.

 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
83.045 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.875 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.875 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The assessment factors were chosen according to R.8 ECHA Guidance document. See details above.