Registration Dossier
Registration Dossier
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EC number: 400-390-6 | CAS number: 87787-67-5 FLEXSORB-SE
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.94 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA modified with ECETOC TR110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.89 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-Acute to Chronic (ECHA Default)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already considered in the correction of the dose descriptor (ECHA default)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOR TR110: Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR110
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Default
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.39 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA modified with ECETOC TR110
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic (ECHA Default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Default
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC TR110: Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOR TR110
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Default
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Correction of Dose Descriptors
Although the main focus of the hazard assessment was the Category 1A corrosivity of the substance, long-term DNELs were derived for systemic inhalation and dermal exposure, to ensure that the prescribed operational conditions and risk management measures were suitable protective against the hazards identified for repeated dose toxicity effects (sub-acute NOAEL = 60 mg/kg bw/d).
Correction of the starting dose descriptors, to allow derivation of DNELs, was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.
Inhalatory NOAEC
The corrected inhalatory NOAEC was calculated, using route-to-route extrapolation as follows:
| Corrected NOAEC | = oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x (sRVhuman/wRV) |
| = 60 mg/kg bw/d x (1/0.38m2/kg/d) x (1/2) x (6.7 m3 (8h) / 10 m3 (8h)) | |
| = 52.89 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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.
