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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.8 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
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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:
4.2 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
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
420 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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

Selection of the relevant dose descriptors:


NOAEL(repeated dose toxicity) = 300 mg/kg bw/d


NOAEL(developmental toxicity) = 500 mg/kg bw/d


 


Modification of the relevant dose descriptors to the correct starting point: 


Oral absorption


The physicochemical properties of the substance are favourable for oral absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, the default value of 50% is taken into consideration dermal (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Dermal absorption


The physicochemical properties of the substance are favourable for dermal absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, the default correction factor for route-to-route extrapolation from oral to dermal (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Inhalation absorption


The physicochemical properties of the substance are favourable for inhalation absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, default correction factor for route-to-route extrapolation from oral to inhalation (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Correction parameters used:


















Correction for differences in respiratory volume (worker)



2.63



Correction for light activity at work



0.67



Correction for differences between human and experimental exposure conditions (worker)



1.4



 


DNELs derived from the 90 d repeated dose toxicity study


Starting point: 300 mg/kg bw/d NOAEL(repeated dose toxicity)


Route of original study: oral


Worker-DNEL long-term for inhalation route (systemic): 14.8 mg/m³


Worker-DNEL long-term for dermal route (systemic): 4.2 mg/kg bw/d


 


Assessment factors used:






































AF for dose response relationship



1 (Default (DNEL calculator))



AF for difference in duration of exposure



2 (Default (DNEL calculator))



AF for interspecies differences (allometric scaling)



1 (Default (DNEL calculator)) for inhalation


 


4 (Default (DNEL calculator)) for dermal exposure



AF for other interspecies differences



2.5 (Default (DNEL calculator))



AF for intraspecies differences



5 (Default (DNEL calculator))



AF for the quality of the whole database



1 (Default (DNEL calculator))



AF for remaining uncertainties



1 (no remaining uncertainties)



Overall assessment factor



25 (inhalation)


100 (oral)



 


DNELs derived from the prenatal developmental toxicity study


Starting point: 500 mg/kg bw/d NOAEL (developmental toxicity)


Route of original study: oral


Worker-DNEL long-term for inhalation route (systemic): 49.3 mg/m³


Worker-DNEL long-term for dermal route (systemic): 14 mg/kg bw/d


 


Assessment factors






































AF for dose response relationship



1 (Default (DNEL calculator))



AF for difference in duration of exposure



1 (no time extrapolation required, since the susceptible window is fully covered)



AF for interspecies differences (allometric scaling)



1 (Default (DNEL calculator)) for inhalation


 


4 (Default (DNEL calculator)) for dermal exposure



AF for other interspecies differences



2.5 (Default (DNEL calculator))



AF for intraspecies differences



5 (Default (DNEL calculator))



AF for the quality of the whole database



1 (Default (DNEL calculator))



AF for remaining uncertainties



1 (no remaining uncertainties)



Overall assessment factor



12.5 (inhalation)


50 (oral)



 


The DNELs for developmental toxicity are higher than those for repeated dose toxicity. Thus, the repeated dose toxicity-DNELs are also protective for development.


 


Short-term systemic effects 


The acute/short term inhalation DNEL for systemic effects was not required, since the substance is unlikely to exert significant acute toxicity via the inhalation route.


 


The acute/short term exposure dermal DNEL for systemic effects was not derived, since no hazard was identified for Methyl benzoate for dermal toxicity. It is anticipated that incidences of potential acute dermal exposure to the substance are covered with the DNEL for dermal long-term exposure of workers.


 


Long-term local effects 


The long-term inhalation and dermal DNELs for local effects were not derived, since no local irritation potential was identified in skin irritation studies and only slight, transient effects on conjunctivae were observed.


 


Short-term local effects 


The acute/short term inhalation and dermal DNELs for local effects were not derived, since no local irritation potential was identified in skin irritation studies and only slight, transient effects on conjunctivae were observed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.61 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):
50
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
131 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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:
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:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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

Selection of the relevant dose descriptors:


NOAEL(repeated dose toxicity) = 300 mg/kg bw/d


NOAEL(developmental toxicity) = 500 mg/kg bw/d


 


Modification of the relevant dose descriptors to the correct starting point: 


Oral absorption


The physicochemical properties of the substance are favourable for oral absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, the default value of 50% is taken into consideration dermal (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Dermal absorption


The physicochemical properties of the substance are favourable for dermal absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, the default correction factor for route-to-route extrapolation from oral to dermal (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Inhalation absorption


The physicochemical properties of the substance are favourable for inhalation absorption (molecular weight = 136.15 g/mol, log Kow = 2.24). Therefore, default correction factor for route-to-route extrapolation from oral to inhalation (Guidance on Information Requirements and Chemical Safety Assessment, R8).


 


Correction parameters used:














Correction for differences in respiratory volume (general population)



0.87



Correction for differences between human and experimental exposure conditions (general population)



1



 


DNELs derived from the 90 d repeated dose toxicity study


Starting point: 300 mg/kg bw/d NOAEL(repeated dose toxicity)


Route of original study: oral


General population-DNEL long-term for inhalation route (systemic): 2.61 mg/m³


General population-DNEL long-term for dermal route (systemic): 1.5 mg/kg bw/d


General population-DNEL long-term for dermal route (systemic): 1.5 mg/kg bw/d


 


Assessment factors used:






































AF for dose response relationship



1 (Default (DNEL calculator))



AF for difference in duration of exposure



2 (Default (DNEL calculator))



AF for interspecies differences (allometric scaling)



1 (Default (DNEL calculator)) for inhalation


 


4 (Default (DNEL calculator)) for dermal and oral exposure



AF for other interspecies differences



2.5 (Default (DNEL calculator))



AF for intraspecies differences



10 (Default (DNEL calculator))



AF for the quality of the whole database



1 (Default (DNEL calculator))



AF for remaining uncertainties



1 (no remaining uncertainties)



Overall assessment factor



50 (inhalation)


200 (dermal and oral)



 


DNELs derived from the prenatal developmental toxicity study


Starting point: 500 mg/kg bw/d NOAEL (developmental toxicity)


Route of original study: oral


General population-DNEL long-term for inhalation route (systemic): 8.7 mg/m³


General population-DNEL long-term for dermal route (systemic): 5 mg/kg bw/d


General population-DNEL long-term for oral route (systemic): 5 mg/kg bw/d


 


Assessment factors






































AF for dose response relationship



1 (Default (DNEL calculator))



AF for difference in duration of exposure



1 (no time extrapolation required, since the susceptible window is fully covered)



AF for interspecies differences (allometric scaling)



1 (Default (DNEL calculator)) for inhalation


 


4 (Default (DNEL calculator)) for dermal exposure



AF for other interspecies differences



2.5 (Default (DNEL calculator))



AF for intraspecies differences



10 (Default (DNEL calculator))



AF for the quality of the whole database



1 (Default (DNEL calculator))



AF for remaining uncertainties



1 (no remaining uncertainties)



Overall assessment factor



25 (inhalation)


100 (dermal and oral)



 


The DNELs for developmental toxicity are higher than those for repeated dose toxicity. Thus, the repeated dose toxicity-DNELs are also protective for development.


 


Short-term systemic effects 


The acute/short term inhalation DNEL for systemic effects was not required, since the substance is unlikely to exert significant acute toxicity via the inhalation route.


 


The acute/short term exposure dermal DNEL for systemic effects was not derived, since no hazard was identified for Methyl benzoate for dermal toxicity. It is anticipated that incidences of potential acute dermal exposure to the substance are covered with the DNEL for dermal long-term exposure of workers.


 


Long-term local effects 


The long-term inhalation and dermal DNELs for local effects were not derived, since no local irritation potential was identified in skin irritation studies and only slight, transient effects on conjunctivae were observed.


 


Short-term local effects 


The acute/short term inhalation and dermal DNELs for local effects were not derived, since no local irritation potential was identified in skin irritation studies and only slight, transient effects on conjunctivae were observed.