Registration Dossier
Registration Dossier
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EC number: 239-707-6 | CAS number: 15630-89-4
Toxicological Summary
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:
- 5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
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:
- DNEL (Derived No Effect Level)
- Value:
- 12.8 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.8 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The relevant routes for occupational exposure to sodium percarbonate are inhalation and dermal contact, whereas oral exposure can be excluded. No systemic effects of exposure to the substance are expected and only DNELs covering local effects are derived for these two routes.
Sodium percarbonate is an addition compound of hydrogen peroxide and sodium carbonate. Based on the molecular formula, the pure substance sodium percarbonate contains 32.5 % hydrogen peroxide and 67.5 % sodium carbonate (based on weight). However, in reality the available Active Oxygen (AVOX) content of sodium percarbonate is about 13.5 %. This is equivalent to a hydrogen peroxide content of about 28.7 %. No systemic effects of sodium percarbonate are anticipated because the substance is not systemically available. Sodium percarbonate causes local irritation effects (OECD 2006). The irritation effect of sodium percarbonate mainly can be explained by the presence of hydrogen peroxide and to a lesser extent by the alkaline sodium carbonate formed during the dissociation of sodium percarbonate (OECD 2006).
The relevant routes for occupational exposure to sodium percarbonate are inhalation and dermal contact, whereas oral exposure can be excluded. No systemic effects of exposure to the substance are expected and only DNELs covering local effects are derived for these two routes. The same routes are relevant for exposure of consumers.
Inhalation of sodium percarbonate results in an irritation of the respiratory system. The available studies on the acute toxicity of the substance show that sodium percarbonate has no systemic effects, while the local effects (irritation) of sodium percarbonate can be mainly explained by the presence of hydrogen peroxide.
For hydrogen peroxide the TLV (ACGIH, 2008) is 1.4 mg/m3 (1 ppm). In 2008 the SCOEL has also proposed an EU OEL value of 1.4 mg/m3 for hydrogen peroxide. This value is also the existing OEL value in many European countries. Based on a hydrogen peroxide content of 28.7 % the equivalent OEL for sodium percarbonate would be 5 mg/m3.
The exposure to sodium carbonate at this OEL value for sodium percarbonate of 5 mg/m3 would be about 5 * 0.675 = 3.4 mg/m3 which is significantly lower than the limit value of sodium carbonate (10 mg/m3).
In the context of the EU Risk assessment of sodium perborate, a No Adverse Effect Concentration (NAEC) for inhalation has been derived for sodium perborate based on read across to hydrogen peroxide. Therefore read across to hydrogen peroxide is an acceptable approach to derive an OEL for sodium percarbonate.
No irritation was induced by undiluted sodium percarbonate (purity of > 88 %, approximately 80 mg/cm2) applied to the skin and moistened with saline in tests performed for four hours under semi-occlusive conditions with rabbits. Slight effects were fully reversible during the observation period of 14 days. A human patch test applying 0.2 g of the substance (88 to 92 % purity, approximately 64 mg/cm2) to the skin of 26 volunteers for up to 4 hours under semi-occlusive conditions showed that sodium percarbonate had no skin irritation potential in humans under the test conditions.
Based upon these considerations, it is concluded that the dose of 64 mg/cm2 applied in the human patch (skin irritation) test is a suitable starting point for the derivation of the DNEL covering local dermal effects occurring in workers and the consumers.
Sodium percarbonate can be corrosive to the eye (R41 according to Directive 67/548/EEC) so that there is no need to derive a DNEL for eye exposure.
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:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
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:
- DNEL (Derived No Effect Level)
- Value:
- 6.4 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.4 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
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
The substance is not systemically available and therefore does not exhibit systemic effects. No systemic DNELs are derived. For consumers, only the dermal route is relevant and only a dermal DNEL is derived.
No irritation was induced by undiluted sodium percarbonate (purity of > 88 %, approximately 80 mg/cm2) applied to the skin and moistened with saline in tests performed for four hours under semi-occlusive conditions with rabbits. Slight effects were fully reversible during the observation period of 14 days. A human patch test applying 0.2 g of the substance (88 to 92 % purity, approximately 64 mg/cm2) to the skin of 26 volunteers for up to 4 hours under semi-occlusive conditions showed that sodium percarbonate had no skin irritation potential in humans under the test conditions.
Based upon these considerations, it is concluded that the dose of 64 mg/cm2 applied in the human patch (skin irritation) test is a suitable starting point for the derivation of the DNEL covering local dermal effects occurring in workers and the consumers.
Sodium percarbonate can be corrosive to the eye (R41 according to Directive 67/548/EEC) so that there is no need to derive a DNEL for eye exposure.
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