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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

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