Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
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:
14.03 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL
Value:
350.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEC of 200mg/m3 in a 13-week inhalation toxicity study with rats and mice (Medinsky, 1990); No data on differences of bioavailabilities between human and rats/mice (no correction necessary); Route of exposure: inhalation to dermal (no correction necessary); Exposure conditions: exposure of workers is not expected to increase the absorption (no correction necessary); Differences in respiratory volumes: 0.57 (=0.38/6.7x10); Dermal NOAEL=200/0.57=350.9 mg/kg/day

AF for dose response relationship:
1
Justification:
starting point is a NOAEL (no correction necessary)
AF for differences in duration of exposure:
2
Justification:
13-week=subchronic vs. chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Starting dose descriptor from inhalation study (differences in the allometry are assumed to be compensated by differences in the respiration rate).
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
sufficient (no correction necessary)
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

The main risk to workers from handling Azodicarbonamide (ADCA) is from exposure by the inhalation route. ADCA has been classified as a respiratory sensitiser based on on occupational health data (case reports and epidemiological data of respiratory effects).

Therefore the qualitative approach (risk characterisation) is used first to define the RMMs and OCs. An inhalation DNEL has also been derived based on the results available on the respiratory toxicity of ADCA which are discussed in the report attached below. There appears to be a safe concentration of exposure to workers between 0.5 and 1.5 mg/m3 time weighted over an 8 hour work day. Therefore the inhalation DNEL has been set at 0.5mg/m3. This DNEL is used to judge the remaining/residual likelihood of risks after these RMMs and OCs are implemented.

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