Registration Dossier
Registration Dossier
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EC number: 943-366-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.6 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: Guidance on Assessment Factors to derive a DNEL - ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 3
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.6 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: Guidance on Assessment Factors to derive a DNEL - ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 3
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Derivation of DNEL-workers
The most relevant route of worker exposure is via inhalation route. Dermal exposure would not be anticipated to be significant route of exposure under standard occupational practice, because of protective procedures and equipment used.
Hazard via inhalation route – long-term local and systemic effects
Hazard assessment of the target substance is based on the most hazardous substance in the mixture, acetic anhydride.
The OEL levels in Europe for acetic anhydride are mostly in the range from 0.5 to 10 ppm (2.1 – 42 mg/m3) (8h TWA and 15min STEL), typical value being currently 5 ppm.
However, the monitoring data indicates that levels of acetic anhydride are below 1 ppm 8h TWA (4.2 mg/m3) in facilities where acetic anhydride is produced and where the major use of acetic anhydride takes place. Thus, this value is also used as DNELs.
DNEL worker chronic systemic by inhalation route = 4.2 mg/m³.
Hazard via inhalation route – acute local and systemic effects
ACGIH proposes as a default that “excursions in worker exposure levels may exceed 3 times the TLV-TWA for no more than a total of 30 minutes during a workday, and under no circumstances they should exceed 5 times the TLV-TWA, provided that the TLV-TWA is not exceeded.” This maximum recommended excursion is derived from the variability generally observed for actual industrial processes (ACGIH, 2008). This approach of ACGIH ie. using AF of 3 for the derivation of a DNEL acute as specific data are not available by which a data-based DNEL acute can be justified.
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.
