Registration Dossier

Administrative data

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).