Registration Dossier
Registration Dossier
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EC number: 616-436-5 | CAS number: 77098-07-8
Toxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
