Benzoic acid, 2-hydroxy-, C14-18-alkyl derivs.

Toxicological Summary

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:

no hazard identified

DNEL related information

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:

no hazard identified

DNEL related information

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 benzoic acid, 2 -hydroxy-,C14 -18 alkyl derivs. is the OECD 407 study (Beerens-Heijnen, 2015) with a NOAEL of 100 mg/kg bw/day for increased liver weights in males and females. As there are no chronic or sub-chronic studies, this sub-acute study has been used to derive a chronic DNEL.

Acute exposure

An acute DNEL was not required. In studies (Latour, 506481 and 506482, 2014) no acute toxicity was observed in doses of up to 2000 mg/kg. In addition, the substance has no consumer uses, so only workers will be exposed to benzoic acid, 2 -hydroxy-C14 -18 alkyl derivs. Since exposure to workers is controlled to remain below the chronic DNEL, acute exposures are not expected, so this DNEL is not required.

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 significant exposure of the general public to benzoic acid, 2-hydroxy-,C14-18 alkyl derivs. (see IUCLID dossier Section 3.5).