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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 236-502-3 | CAS number: 13410-58-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.73 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:
- 62.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 55.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The corrected dose descriptor for inhalation for workers = [62.5 mg/kg bw/day] / [0.38 m3/kg bw/day] × [6.7 m3/10m3] × [1/2]* = 55.1 mg/m3
*A default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) for oral-to-inhalation extrapolation (ECHA, 2012).
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 62.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A maximal absorption was already occurred by the oral route and no additional correction factor was introduced.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
References
ECHA (2012) Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012.
ECHA (2016) Guidance on information requirements and chemical safety assessment Part E: risk characterisation, Version 3.0, May 2016.
Enoch, S.J., Roberts, D.W., Cronin, M.T. (2009) Electrophilic reaction chemistry of low molecular weight respiratory sensitizers. Chem Res Toxicol. 22(8):1447-1453.
Gamer, A.O. (2005a) Hydrierter Bisphenol-A-bisglycidylether – acute oral toxicity study in rats. Report No. 10A0057/041015. Unpublished report.
Gamer, A.O. and Leibold, E. (2005b) Hydrierter Bisphenol-A-bisglycidylether - Murine Local Lymph Node Assay (LLNA). Report No. 45H0057/042047. Unpublished report.
Kimber, I., Dearman, R.J. (2005) What makes a chemical a respiratory sensitizer? Curr Opin Allergy Clin Immunol. 5(2):119-124.
Rodford, R., Patlewicz, G., Walker, J.D., Payne, M.P. (2003) Quantitative structure-activity relationships for predicting skin and respiratory sensitization. Environ Toxicol Chem. 22(8):1855-1861.
Saitoh, T. (2019) Combined repeated dose and reproduction/developmental toxicity test of YX8000D by oral administration in rats. Report No. P180450. Unpublished report.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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.
