Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 252-917-2 | CAS number: 36211-43-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.9 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132.24 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 3,5,5-trimethylhexanoic acid (IsoC9), i.e. expressed as mg IsoC9/kg bw/day and mg IsoC9/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium bis(3,5,5-trimethylhexanoate)/m³". Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default: Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default: remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default: worker
- AF for the quality of the whole database:
- 1
- Justification:
- High quality of evidence
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.08 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).
Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 3,5,5-trimethylhexanoic acid (IsoC9), i.e. expressed as mg IsoC9/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium bis(3,5,5-trimethylhexanoate)/kg bw/day".
Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default: rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default: remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default: Worker
- AF for the quality of the whole database:
- 1
- Justification:
- high quality weight of evidence
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
In order to evaluate toxicological properties of the substance barium bis(3,5,5-trimethylhexanoate), information on the assessment entities barium cation and neodecanoate anion, as representative of the 3,5,5-trimethylhexanoate anion, were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for barium bis(3,5,5-trimethylhexanoate).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.47 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 65.22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 3,5,5-trimethylhexanoic acid (IsoC9), i.e. expressed as mg IsoC9/kg bw/day and mg IsoC9/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium bis(3,5,5-trimethylhexanoate)/m³". Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default: rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default: remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default: general population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.54 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).
Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 3,5,5-trimethylhexanoic acid (IsoC9), i.e. expressed as mg IsoC9/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium bis(3,5,5-trimethylhexanoate)/kg bw/day".
Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default: rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default: remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default: general population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.54 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 3,5,5-trimethylhexanoic acid (IsoC9), i.e. expressed as mg IsoC9/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium bis(3,5,5-trimethylhexanoate)/kg bw/day".
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default: rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default: remianing differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default: general population
- AF for the quality of the whole database:
- 1
- Justification:
- high quality
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
In order to evaluate toxicological properties of the substance barium bis(3,5,5-trimethylhexanoate), information on the assessment entities barium cation and neodecanoate anion, as representative of the 3,5,5-trimethylhexanoate anion, were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for barium bis(3,5,5-trimethylhexanoate).
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.
