Reaction product aqueous Phosphoric Acid, 2-Butoxyethanol and 4,4'-Isopropylidenediphenol-Epichlorohydrin

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.11 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:

250 mg/kg bw/day

Value:

308 mg/m³

Explanation for the modification of the dose descriptor starting point:

Extrapoloation from oral toxicity data to the inhalation route.

DNEL = 250 mg/kg/day * ((6.7/10) * (0.5) * (7/5) * (1/0.38)) = (308.6 mg/m3 / 75) = 4.11 mg/m3

AF for dose response relationship:

1

Justification:

ECHA R.8 guidance (route to route ABS included in dose descriptor)

AF for differences in duration of exposure:

6

Justification:

ECHA R.8 guidance (sub-acute to chronic)

AF for interspecies differences (allometric scaling):

1

Justification:

ECHA R.8 guidance (allometric scaling not required)

AF for other interspecies differences:

2.5

Justification:

ECHA R.8 guidance (interspecies rat to human)

AF for intraspecies differences:

5

Justification:

ECHA R.8 guidance (intraspecies worker)

AF for the quality of the whole database:

1

Justification:

Reliable OECD 422 study available.

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties

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:

1.17 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:

250 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

350 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL 250 mg/kg bw day (OECD 422); no required changes from POD.

AF for dose response relationship:

1

Justification:

Starting point was a NOAEL, oral to dermal (route-to-route extrapolation: ECHA R.8 value)

AF for differences in duration of exposure:

6

Justification:

Sub-acute to chronic (ECHA R.8 value)

AF for interspecies differences (allometric scaling):

4

Justification:

Allometric scaling required (rat to humans; ECHA R.8 value)

AF for other interspecies differences:

2.5

Justification:

Interspecies rat to human (ECHA R.8 value)

AF for intraspecies differences:

5

Justification:

Intraspecies worker (ECHA R.8 value)

AF for the quality of the whole database:

1

Justification:

Reliable study available

Justification:

Not required

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

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:

medium hazard (no threshold derived)

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