Registration Dossier
Registration Dossier
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EC number: 231-765-0 | CAS number: 7722-84-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Animal toxicity studies performed with hydrogen peroxide via the oral (Finlay 1996, Freeman 1997) and inhalation routes (Janssen 1995, Kilgour 2002, Staal 2014) give convincing evidence that aqueous solutions of the substance produce only local irritation effects in the gastrointestinal and respiratory tracts. These effects depend mainly on the magnitude of the exposure concentrations rather than the duration of exposure. No systemic effects caused by acute and repeated oral or inhalation exposure to hydrogen peroxide were observed in the studies. This is considered to be due to the limited bioavailability of hydrogen peroxide. Consequently, it is not necessary to derive DNELs for systemic effects caused by short-term and long-term exposure. Local dermal effects are depending on the concentration of hydrogen peroxide in the solution rather than on the amount of substance deposited on the skin. Solutions containing 35% w/w or more hydrogen peroxide are irritating to the skin and workers need to use appropriate skin protection such as chemical resistant gloves and coveralls. It is recommended that workers handling solutions containing less than 35% w/w hydrogen peroxide use appropriate skin protection in order to avoid dermal exposure to the substance. Hydrogen peroxide solutions are irritating to the eyes at concentrations ranging from 5% to <8% and may cause irreversible damage to the eyes at concentrations equal to or greater than 8%. Workers handling concentrated solutions of hydrogen peroxide are obliged to wear appropriate, chemical resistant safety glasses or use face shields. The DNEL for acute inhalation exposure is the occupational short-term exposure limit proposed by the SCOEL committee (SCOEL 2008) and the DNEL for long-term exposure is the occupational exposure limit set for hydrogen peroxide in most countries of the European Union (European Commission 2003).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.93 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Animal toxicity studies performed with hydrogen peroxide via the oral (Finlay 1996, Freeman 1997) and inhalation routes (Janssen 1995, Kilgour 2002, Staal 2014) give convincing evidence that aqueous solutions of the substance produce only local irritation effects in the gastrointestinal and respiratory tracts. These effects depend mainly on the magnitude of the exposure concentrations rather than the duration of exposure. No systemic effects caused by acute and repeated oral or inhalation exposure to hydrogen peroxide were observed in the studies. This is considered to be due to the limited bioavailability of hydrogen peroxide. Consequently, it is not necessary to derive DNELs for systemic effects caused by short-term and long-term exposure. Local dermal effects are depending on the concentration of hydrogen peroxide in the solution rather than on the amount of substance deposited on the skin. Solutions containing 35% w/w or more hydrogen peroxide are irritating to the skin and workers need to use appropriate skin protection such as chemical resistant gloves and coveralls. It is recommended that workers handling solutions containing less than 35% w/w hydrogen peroxide use appropriate skin protection in order to avoid dermal exposure to the substance. Hydrogen peroxide solutions are irritating to the eyes at concentrations ranging from 5% to <8% and may cause irreversible damage to the eyes at concentrations equal to or greater than 8%. Workers handling concentrated solutions of hydrogen peroxide are obliged to wear appropriate, chemical resistant safety glasses or use face shields. The DNEL for acute inhalation exposure is the occupational short-term exposure limit proposed by the SCOEL committee (SCOEL 2008) and the DNEL for long-term exposure is the occupational exposure limit set for hydrogen peroxide in most countries of the European Union (European Commission 2003), but recalculated for the exposure conditions typical of members of the general public.
The long-term DNEL for consumers was derived in the following way:
1) starting point was the occupational threshold, so 1.4 mg/m3;
2) differences between body weight of workers (70 kg) and consumers (60 kg) were taken into account, so the factor 60/70 was introduced;
3) differences in the inhalation volume were considered (10 m3 per shift for worker, 20 m3 per day for consumer), so the factor 10/20 was introduced (this also accounts for the different duration of exposure);
4) differences in the frequency of exposure were considered, as workers are exposed only 5 days a week while consumers are continuously exposed during 7 days a week, so the factor 5/7 was introduced;
5) supposed a safety factor of 5 (for intraspecies differences) was applied to derive the occupational threshold value, an additional factor of 2 has to be applied because the safety factor for intraspecies differences is 10 for consumers.
The long-term DNEL for consumers was thus calculated by the following equation
DNELconsumer = 1.4 * 60/70 * 10/20 *1/2 * 5/7 = 0.21 mg/m3
In the case of the short-term DNEL, the calculation was slightly modified, because the same duration of exposure was considered (15 minutes). In this case the inhalation volume of the worker is about 0.313 m3 and the inhalation volume of the consumer is about 0.208 m3. An additional factor of 2 has to be applied because the safety factor for intraspecies differences is 10 for consumers.
The short-term DNEL was calculated in the following way
DNELconsumer = 3 * 60/70 * 0.313/0.208 * 1/2 = 1.93 mg/m3
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