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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.56 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Based on the method by the American Conference of Governmental Industrial Hygienists (ACGIH, 2014) using the determined RD50 as most sensitive endpoint.
Overall assessment factor (AF):
30
Dose descriptor:
other: RD50
Value:
17 mg/m³
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.56 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Based on the method by the American Conference of Governmental Industrial Hygienists (ACGIH, 2014) using the determined RD50 as most sensitive endpoint.
Overall assessment factor (AF):
30
Dose descriptor starting point:
other: RD50
Value:
17 mg/m³
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"

Workers - 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:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Inhalation


The available acute inhalation studies with aerosols and vapour derived from different peracetic acid solutions suffered from the difficulty of generating and maintaining a stable atmosphere of peracetic acid and accurate measurement of the composition of the test atmosphere and particle size of the aerosol. The reported LC50 values should, therefore, be treated with circumspection. The 4h-LC50 values ranged from 76 to >241 mg/m³ based on peracetic acid. A common finding of those studies was local irritation of the respiratory tract, which seems more pronounced with aerosols than vapours, so that peracetic acid is consequently classified with STOT SE 3.


 


In order to determine a threshold level reflecting the irritation potency, the RD50 of 5.4 ppm (approx. 17 mg/m³) is taken into account, which was derived Gagnaire (2002). RD50 values have been successfully shown to predict safe industrial exposures if sensory irritation is the most sensitive endpoint as developed by the American Conference of Governmental Industrial Hygienists (ACGIH 2014; Kuwabara, 2007).


 


According to this, it also has been demonstrated for a wide range of chemicals that at 0.1 times the RD50, humans would experience a slight discomfort and at 0.03 times the RD50 (RD50/30) no effects have been encountered.


 


As the most prominent effects of peracetic acid are due to the corrosive properties which is more a dose-dependent rather than a time-dependent effect, the use of the RD50 as a starting point for derivation of the DNEL for the inhalation route (acute and long-term, local) is justified. Thus, the DNEL is derived as follows:


 


DNEL = RD50 / AF = 17 mg/m³ / 30 = 0.56 mg/³


 


No systemic DNELs are derived as due to the high reactivity and rapid degradation, peracetic acid is not expected to enter the body and become systemically available. Due to the corrosive properties, inhalation contact will result in local effects at the site of first contact. Thus, it was considered sufficient to derive DNELs for local effects based on a RD50 reflecting the irritation and corrosion potency. 


 


Dermal


Due to the corrosive properties, dermal contact will result in local effects at the site of first contact. It was also found that due to its high reactivity and rapid degradation, peracetic acid is not expected to enter the body and become systemically available after dermal application. As all systemic observations and effects after single or repeated exposure were seen after oral application these are considered to be secondary to a locally irritating/corrosive effect. Hence, a DNEL for systemic effects, long-term and acute, are not derived.


 


Peracetic acid is categorised in the “high hazard” band for local effects (long-term and acute) on skin and eyes according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1.


 


 


References:


 


ACGIH. TLVs and BEIs, Based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH: American Conference of Governmental Industrial Hygienists; 2014.


 


Yu Kuwabara, George V. Alexeeff, Rachel Broadwin, and Andrew G. Salmon, Evaluation and Application of the RD50 for Determining Acceptable Exposure Levels of Airborne Sensory Irritants for the General Public; Environ Health Perspect. 2007 November; 115(11): 1609–1616.

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:
DNEL (Derived No Effect Level)
Value:
0.28 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Based on the method by the American Conference of Governmental Industrial Hygienists (ACGIH, 2014) using the determined RD50 as most sensitive endpoint.
Overall assessment factor (AF):
60
Dose descriptor:
other: RD50
Value:
17 mg/m³
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.28 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Based on the method by the American Conference of Governmental Industrial Hygienists (ACGIH, 2014) using the determined RD50 as most sensitive endpoint.
Overall assessment factor (AF):
60
Dose descriptor starting point:
other: RD50
Value:
17 mg/m³
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"
Justification:
See "Explanation for hazard conclusion"

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:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
high hazard (no threshold derived)

Additional information - General Population

Inhalation


 


The available acute inhalation studies with aerosols and vapour derived from different peracetic acid solutions suffered from the difficulty of generating and maintaining a stable atmosphere of peracetic acid and accurate measurement of the composition of the test atmosphere and particle size of the aerosol. The reported LC50 values should, therefore, be treated with circumspection. The 4h-LC50 values ranged from 76 to >241 mg/m³ based on peracetic acid. A common finding of those studies was local irritation of the respiratory tract, which seems more pronounced with aerosols than vapours, so that PAA is consequently classified with STOT SE 3.


 


In order to determine a threshold level reflecting the irritation potency, the RD50 of 5.4 ppm (approx. 17 mg/m³) is taken into account, which was derived by Gagnaire (2002). RD50 values have been successfully shown to predict safe industrial exposures if sensory irritation is the most sensitive endpoint as developed by the American Conference of Governmental Industrial Hygienists (ACGIH 2014; Kuwabara, 2007).


 


According to this, it also has been demonstrated for a wide range of chemicals that at 0.1 times the RD50, humans would experience a slight discomfort and at 0.03 times the RD50 (RD50/30) no effects have been encountered.


 


As the most prominent effects of peracetic acid are due to the corrosive properties which is more a dose-dependent rather than a time-dependent effect, the use of the RD50 as a starting point for derivation of the DNEL for the inhalation route (acute and long-term, local) is justified.


 


To reflect the intraspecies difference among the general population compare worker, an additional assessment factor of two is applied. Thus, the DNEL is derived as follows:


 


DNEL = RD50 / AF = 17 mg/m³ / (30* 2) = 0.28 mg/³


 


No systemic DNELs are derived as due to the high reactivity and rapid degradation, peracetic acid is not expected to enter the body and become systemically available. Due to the corrosive properties, inhalation contact will result in local effects at the site of first contact. Thus, it was considered sufficient to derive DNELs for local effects based on a RD50 reflecting the irritation and corrosion potency. 


 


Dermal


 


Due to the corrosive properties dermal contact will result in local effects at the site of first contact. It was also found that due to its high reactivity and rapid degradation, peracetic acid is not expected to enter the body and become systemically available after dermal application. As all systemic observations and effects after single or repeated exposure were seen after oral application these are considered to be secondary to a locally irritating/corrosive effect. Hence, a DNEL for systemic effects, long-term and acute, are not derived.


 


Peracetic acid is categorised in the “high hazard” band for local effects (long-term and acute) on skin and eyes according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1.


 


Oral


 


Due to the corrosive properties of peracetic acid, oral contact will result in local effects at the site of first contact. All systemic observations and effects after single or repeated exposure are considered to be secondary to a locally irritating/corrosive effect as peracetic acid is not expected to become systemically available due to its high reactivity and rapid degradation. Hence, a DNEL for systemic effects after oral exposure is not derived. 


 


 


References:


 


ACGIH. TLVs and BEIs, Based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH: American Conference of Governmental Industrial Hygienists; 2014.


 


 


Yu Kuwabara, George V. Alexeeff, Rachel Broadwin, and Andrew G. Salmon, Evaluation and Application of the RD50 for Determining Acceptable Exposure Levels of Airborne Sensory Irritants for the General Public; Environ Health Perspect. 2007 November; 115(11): 1609–1616.