Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.509 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33.333 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in the ECHA guidance document "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008

 The DNEL is calculated according to the general formula:

Corrected starting point: NOAEL/AF

Using the no-adverse effect level of oral study (NOAEL = 1000 mg/kg/day, 28-day, oral gavage study), the corrected starting point (NAEC) for the inhalative route is calculated according following formula for worker: = NOAEL* 1/0.38*6.7/10, where 6.7/10 mg/m³ represents the human light activity and 0.38 m³/kg is the standard breathing volume for the rats for 8 hours exposure for workers.

Using the no-adverse effect level of oral study (NOAEL= 1000 mg/kg/day, 28 -day, oral gavage study), the correct starting point (NAEL) for the dermal route is calculated taking in consideration the absorption difference (0.1), being the dermal absorption (calculated with DERMWIN Skin Permeability Model) of β-alanine very low (Dermal Absorption 0.00029 mg/cm²/h; absorption potential: 10%).

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.797 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.667 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.667 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in the ECHA guidance document "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008

The DNEL is calculated according to the general formula:

Corrected starting point: NOAEL/AF

 

Using the no-adverse effect level of oral study (NOAEL= 1000 mg/kg/day, 28-day, oral gavage study), the corrected starting point for the inhalative route (NAEL) is calculated according following formula for general population: = NOAEL* 1/1.15, where 1.15 m³/kg is the standard breathing volume for rat for 24 hours exposure of general public.

Using the no-adverse effect level of oral study (NOAEL= 1000 mg/kg/day, 28-day, oral gavage study), the correct starting point for the dermal route (NAEL) is calculated taking in consideration the absorption difference (0.1), being the dermal absorption (calculated with DERMWIN Skin Permeability Model) of beta-alanine very low (Dermal Absorption 0.00029 mg/cm²/h; absorption potential: 10%).