Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.888 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:
other: NOAEL
Value:
216.595 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
for duration
AF for interspecies differences (allometric scaling):
1
Justification:
for species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.661 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):
3
DNEL extrapolated from long term DNEL

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:
0.206 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:
61.875 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
for duration
AF for interspecies differences (allometric scaling):
4
Justification:
for species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.618 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):
3
DNEL extrapolated from long term DNEL

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

Toxicokinetics

Specific-pathogen free (SPF) and germ-free rats were each given a single oral dose of the14C-preparations of3-Phenoxybenzyl alcoholin 10% Tween 80 (1 ml) at a rate of 9 µmol kg-1. The SPF rats were individually housed in all-glass metabolism cages. The urine and faeces were collected separately for 1 day (germ-free rats), and for up to 7 days (SPF rats). The administered3-Phenoxybenzyl Alcohol was absorbed in the GI tract and metabolized to3-phenoxybenzoic acidand 3-(4-sulphonyloxyphenoxy)benzoic acid. The major metabolites were3-phenoxybenzoic acidand 3-(4-sulphonyloxyphenoxy) benzoic acid in the liver, and3-phenoxybenzoic acidin the blood. At the end of 7 days, a total of 99.4(+0.6)of the % of the dose administered was excreted out of the body of rats in urine and feaces. Thus, it is concluded that the bioaccumulation potential of the chemical3-Phenoxybenzyl alcohol isexpected to be low.

Acute toxicity:

Based upon the study results and available information, the substance 3-Phenoxybenzylalcohol is expected to show acute toxicity effect by the oral route in category 4 and thus will be considered for further classification. Available data indicates that the substance is not likely to exhibit acute toxicity by the inhalation and dermal route of exposure.

Skin & eye irritation:

On the basis of available information, the substance 3-Phenoxybenzylalcohol (CAS NO. 13826-35-2) is likely to be irritating to eyes of rabbits but not irritating to skin of rabbit and is therefore classified as "Not Irritating" to skin and “Irritating “to eye as per the CLP criteria.

Skin sensitisation:

The skin sensitisation effect of3-Phenoxybenzyl alcoholin guinea pig was estimated using QSAR Toolboox version 3.3. The test substance3-Phenoxybenzyl alcoholwas estimated to be non-sensitising to skin of guinea pig. Considering the CLP criteria for classification of substances, it is concluded that3-Phenoxybenzyl alcoholis likely to be non-classified as a skin sensitiser.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.344 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):
150
Modified dose descriptor starting point:
other: NOAEL
Value:
51.578 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
duration
AF for interspecies differences (allometric scaling):
1
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.029 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):
3
DNEL extrapolated from long term DNEL

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:
0.025 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
14.735 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
duration
AF for interspecies differences (allometric scaling):
4
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.073 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):
3
DNEL extrapolated from long term DNEL

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:
0.275 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
165 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
duration
AF for interspecies differences (allometric scaling):
4
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.825 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):
3
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

3-phenoxybenzylic alcohol do not exhibit acute toxicity by dermal and inhalation route of exposure, but the toxicity is observed via oral route. The chemical was not found to be irritating to skin and eye. Available data indicates that the chemical does not exhibit genotoxicity and is not a reproductive and developmental toxin within the dose levels mentioned in the end points.  

 

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 in this case would be to use the repeated toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the oral 165 mg/kg.