Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.7 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):
75
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
353 mg/m³
Explanation for the modification of the dose descriptor starting point:

BAsed on a 28 d feeding study of Di(2 -ethylhexyl)-3,4,5,6 -tetrabromophalate (DEHTBP) in rats.  NOAEL=2000 ppm diet or approximately 200 mg/kg bw/d with the assumption of a feeding rate of the rat of 100 g diet/kg/day. Corrected inhalation NOAEC = 200 (1/0.38)(6.7/10)=353 mg/m3.

AF for dose response relationship:
1
Justification:
Normal dose-response relationship
AF for differences in duration of exposure:
6
Justification:
according to ECHA guidance subcheonic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Toxicokinetic part has been accounted for in the route to route extrapolation in accordance with ECHA guidance.
AF for other interspecies differences:
2.5
Justification:
toxicodynamic part.
AF for intraspecies differences:
5
Justification:
Default for workers accordign to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Based on a high quality study for read across to the lowest molecular weight component that is supposed to have potetnially the highest bioavailability and potential toxicity.
AF for remaining uncertainties:
1
Justification:
none identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEC
Value:
8.3 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
5.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

No effet after 1 h exposure to a saturated atmosphere. Correction: 8(6.7/10)= 5.36 mg/m3

AF for dose response relationship:
1
Justification:
no effects at saturation
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation exposure corrects already via repiratory volume and frequency (see ECHA guidance)
AF for other interspecies differences:
2.3
Justification:
Dynamikl default factor
AF for intraspecies differences:
5
Justification:
Defautl for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
NOAEC
Value:
353 mg/m³
AF for dose response relationship:
1
Justification:
Normal dose-response relationship
AF for differences in duration of exposure:
6
Justification:
in accordance with ECHA guidance
AF for interspecies differences (allometric scaling):
1
Justification:
already accounted for in the route to route extrapolation, see ECHA guidance.
AF for other interspecies differences:
2.5
Justification:
in accordance with ECHA guidance
AF for intraspecies differences:
5
Justification:
in accordance with ECHA guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
2.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
216
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Normal dose response
AF for differences in duration of exposure:
6
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
2.4
Justification:
Rabbit
AF for other interspecies differences:
2.5
Justification:
in accordance with ECHA guidance
AF for intraspecies differences:
5
Justification:
in accordance with ECHA guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
667 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
NOAEL
Value:
20 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No effects observed

AF for dose response relationship:
1
Justification:
No effects obseved
AF for interspecies differences (allometric scaling):
2.4
Justification:
Rabbit
AF for other interspecies differences:
2.5
Justification:
in accordance with ECHA guidance
AF for intraspecies differences:
5
Justification:
in accordance with ECHA guidance
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1

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:
low hazard (no threshold derived)

Additional information - workers

The reference substance, CAS No. 20566 -35 -2, and structural analogs were used to model the mammalian toxicology of the UVCB substance. See attachment for structures and substances modeled. IUCLID Data Sets and/or OECD SIDS profiles are available on the structural analogs modeled. See attachment for data and references.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The UVCB substance is not sold to the general public. It is used only as a reactive flame retardant in rigid polyurethane foam insulation. Thus, calculations of DNELs for the general population is not needed.