Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
1 750 mg/m³
Explanation for the modification of the dose descriptor starting point:

for route-to-route extrapolation the following factors were applied to come to a human NOAEC: interspecies 4, bw 70 kg, 10 m3 inhalation volume/working day

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
default factor for extrapolation subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
included in the derivation of the NOAEC to account for differences in metabolic rate
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor worker variability
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
10 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

based on similar very low absorption via the oral and the dermal route

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
default factor for extrapolation from sub-schronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for differences in metabolic rate rat versus human
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor for worker variability
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

No adverse effects up to the highest dose tested have been found in any available study on repeated-dose toxicity or on developmental toxicity used for this assessment. As the NOAEL is 1000 mg/kg bw/day, the statement “no hazard identified” is applicable. Due to the substance's low volatility and its use pattern the inhalation route is considered irrelevant as exposure route except for the use in drilling fluids where aerosols can be formed. Therefore next to a DNEL for dermal exposure, a DNEL for inhalation exposure will be derived. In risk assessment the inhalation DNEL will only be taken into account for the drilling fluid use phase.

The DNEL for dermal long-term systemic effects is derived, because exposure via the dermal route cannot be excluded.

 

Acute toxicity

ECHA Guidance R.8 (Chapter R.8.1.2.5) indicates that DNELs for acute toxicity are not required if no acute toxicity hazard leading to classification has been identified. The substance oxidised crude tall oil was not found to be acutely harmful while a low vapour pressure precludes inhalation exposure indicating a low of concern for this route of exposure. No DNELs for acute toxicity are therefore necessary. The DNELs as derived for long-term toxicity are considered to be sufficiently protective for acute effects if any.

Repeated dose toxicity

No adverse effects up to the highest dose tested have been found in the available study on repeated-dose toxicity or developmental toxicity used for assessment. As the NOAEL is 1000 mg/kg bw/day, the statement “no hazard identified” is applicable.

Inhalation long-term

In view of the substance's low volatility and high viscosity, exposure via the inhalation route seems unlikely. However, for part of the life-cycle aerosols may be formed during use of the substance in drilling fluids. Therefore a DNEL for the inhalation route was derived based on route-to-route extrapolation from the oral NOAEL of 1000 mg/kg bw. Based on the toxicokinetic profile the inhalation absorption can be regarded as low (10%), while oral absorption was estimated to be very low (10% absorption as worst case). This leads to a human NOAECinhalation of 1750 mg/m3 (route-to-route extrapolation (1000/4)*(70/10)). Additional assessment factors (AF) are applied to derive the DNEL. The AFs were based on the procedures described ECHA Guidance R.8.

Dermal long-term

The NOAEL for oral repeated dose toxicity of was found to be 1000 mg/kg bw/d in a 90 -day toxicity study. This value is used as the starting point for DNEL derivation for the dermal route.

Based on the toxicokinetic profile the dermal absorption can be regarded as low (10%), while oral absorption was estimated to be very low (10% absorption as a worst case). This leads to a NOAELdermal of 1000 mg/kg bw (route-to-route extrapolation). Additional assessment factors (AF) are applied to derive the DNEL. The AFs were based on the procedures described ECHA Guidance R.8

Long-term DNEL Assessment Factors (Dermal)

Assessment Factor

Worker

Differences in metabolic rate per b. w. (allometric scaling)

2.5

Interspecies remaining differences (toxicodynamic and toxicokinetic)

4

Intraspecies differences

5

Duration extrapolation

(sub-acute/sub-chronic/chronic)

2 (sub-chronic)

Issues related to dose-response

1

Quality of whole database

1

Overall AF

100

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

No consumer exposure is expected