Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
36.732 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):
105
Modified dose descriptor starting point:
NOAEC
Value:
3 856.908 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
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:
20.833 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):
105
Modified dose descriptor starting point:
NOAEL
Value:
2 187.5 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
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:
hazard unknown (no further information necessary)

Additional information - workers

Toxicokinetics

Phenetole like its analogue chemical anisole is hydroxylated in para position and excreted as glucuronide. Since metabolism in most cases leads to detoxification (no toxic effects were observed with anisole upon oral administration) and the metabolites are excreted out of the living system; based on the read-across principle; bio-accumulation potential of phenetole appears to be low.

Acute toxicity

Acute toxicity of phenetole to mouse by the oral route indicates that the substance does not exhibits acute toxicity by the oral route. Similarly the acute values of inhalation for read across substance that is anisole on rats, indicates that the substance does not exhibits acute toxicity by the inhalative route.Moreover the acute toxicity of a similar substance, 4-Methylanisole, on rabbits by the dermal route indicates that the substance does not exhibits acute toxicity by the dermal route. Thus, it can be inferred that the target substance is non toxic to any of the oral, dermal and inhalation route of exposure.

 

Irritation / corrosion

In vivo studies of the substance show that the substance is non irritating to skin and eyes, and so the substance is not classified in any of the category as per the C&L regulation.

 

Sensitisation

According to the quantitative structure activity relationship model prediction, Phenetole was predicted as not being sensitizing to guinea pig skin by Guinea pig maximisation test.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.058 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):
210
Modified dose descriptor starting point:
NOAEC
Value:
1 902.174 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
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:
DNEL (Derived No Effect Level)
Value:
10.417 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):
210
Modified dose descriptor starting point:
NOAEL
Value:
2 187.5 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
AF for intraspecies differences:
5
Justification:
worker default

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:
DNEL (Derived No Effect Level)
Value:
5.208 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):
210
Modified dose descriptor starting point:
NOAEL
Value:
1 093.75 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - General Population

DNEL derivation

 

Phenetole is non acute toxic to oral, dermal and inhalation route, shows no irritation effect to skin and eye, is not genotoxic and is not a developmental or reproductive toxin.

 

In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.

 

In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.

 

A standard approach to deriving DNEL values would be to use the repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 4375 mg/kg bw/d in oral category.