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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Oral to dermal (rat-to-rat) has default value of 1:1
- AF for dose response relationship:
- 1
- Justification:
- Repeat dose study NOAEL (default assessment factor)
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic default value (ECHA table R. 8-5)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor from Rat to Humans (ECHA table R. 8-3)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for worker systemic effects (ECHA table R. 8-6)
- AF for intraspecies differences:
- 5
- Justification:
- Default value for worker systemic effects (ECHA table R. 8-6)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value allocated. Klimisch 1, Reliable without restrictions (ECHA table R. 8-6)
- AF for remaining uncertainties:
- 1
- Justification:
- No potential remaining uncertainties, default value allocated (ECHA table R 8.6)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Justification:
- Default value for worker systemic effects (ECHA R. 8-6)
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.08 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor of 1 considered appropriate
- AF for differences in duration of exposure:
- 1
- Justification:
- Acute to chronic default value, default value allocated (ECOTOC doc 110)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor from Rat to Humans (ECHA table R. 8-3)
- AF for other interspecies differences:
- 1
- Justification:
- Default value for local effects (ECHA table R.8-6)
- AF for intraspecies differences:
- 5
- Justification:
- Default value for worker (ECHA R. 8-6)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value allocated. Klimisch 1, Reliable without restrictions (ECHA table R. 8-6)
- AF for remaining uncertainties:
- 1
- Justification:
- No potential remaining uncertainties, default value allocated (ECHA table R. 8-6)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Justification:
- Allometric scaling factor from Rat to Humans (ECHA table R. 8-3)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The 1995 study (OECD 404) was classified a key study based on its rationale for reliability (Klimisch 1, reliable without restriction). As severe persistent dermal irritation with necrosis and severe erythema persisting until day 14 was observed, Epofloc L-1R warranted classification as category 1C (H314 causes severe burns and eye damage). The 2000 study of the same guideline was also classified a key study (Klimisch 1). In this study, Epofloc L-1R caused only very slight to well-defined dermal irritation, and did not meet the classification criteria for skin corrosion or irritation in accordance with Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Version 4.0, November 2013. Although both are key studies, the 2000 study is the pertinent study following minor test The current batch used in the 2000 study and thereafter has been confirmed as that currently used in the EU. Furthermore, data from two supporting in vitro studies performed in 2014 using the reconstituted, human epidermal 3D-skin model (Klimisch 3, not reliable), and skin corrosion test (OECD 431) (Klimisch 2, reliable with restrictions) both confirmed Epofloc L-1R was not a skin irritant or caused a skin corrosive effect. material changes between tests, a result of the manufacturing process being optimized in 1995 and 2000.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
- Justification:
- No potential remaining uncertainties
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.
