Registration Dossier
Registration Dossier
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EC number: 204-650-8 | CAS number: 123-77-3
Toxicological Summary
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:
- 3 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:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction dermal NOAEL: 300 mg/kg bw/day x 100/100a = 300 mg/kg bw/day
(a % oral/dermal absorption)
- AF for dose response relationship:
- 1
- Justification:
- starting point is a NOAEL (no correction necessary)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Correction for caloric demand from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Factor to correct for toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part). No substance-specific information is available to address this aspect more specifically.
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor to account for difference in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- A reliable study is available
- 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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
