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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.17 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected dose descriptor: 88 mg/m3 = (100 * 1/0.38 * 6.7/10 m3/kg bw/day *0.5 [50% oral abs rat / 100% inhalation abs human])
- AF for dose response relationship:
- 1
- Justification:
- Not required, clear NOAEL derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for conversion of sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required, species differences taken into account in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining species differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- No quality issues with data
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Corrected dose descriptor: 200 mg/kg bw/day = (100 * 2 [50% oral abs rat / 25% dermal abs human])
- AF for dose response relationship:
- 1
- Justification:
- Not required, clear NOAEL derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for conversion of sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating from rat to man.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- No quality issues with data
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The substance is not genotoxic.
Chronic exposure
The critical study for sodium 2-hydroxy-mono-C14-C18 (even numbered)-alkyl benzoate is the OECD 407 study (Beerens-Heijnen, 2015) with a NOAEL of 100 mg/kg bw/day based on increased liver weights in males and females, and increase in ALAT activity. As there are no chronic or sub-chronic studies, this sub-acute study has been used to derive a chronic DNEL.
Acute exposure
Acute DNELs have been set at 3x the long-term DNELs, according to the ECHA guidance, because the substance is classified for acute oral toxicity. The substance has no consumer uses, so only workers will be exposed to sodium 2-hydroxy-mono-C14-C18 (even numbered)-alkyl benzoate. Since exposure to workers is controlled to remain below the chronic DNEL, acute exposures are not expected, however, the acute DNELs would protect for any possible acute adverse effect.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
In accordance ECHA guidance (Chapter R.5: Adaptation of information requirements), no general population DNELs are set because there are no uses that would result in exposure of the general public to sodium 2-hydroxy-mono-C14-C18 (even numbered)-alkyl benzoate (see IUCLID dossier Section 3.5).
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.
