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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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.