Registration Dossier
Registration Dossier
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EC number: 944-119-4 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: based on SCOEL derived for nitric acid
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: SCOEL value derived for short-term exposure to nitric acid
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- other: SCOEL value derived for short-term exposure to nitric acid
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- other: SCOEL value derived for short-term exposure to nitric acid
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)
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
Risk assessment for the registered substance was based on nitric acid.
No systemic toxicity was observed for nitrate compounds, however local toxicity of nitric acid was observed. For local inhalation toxicity, a SCOEL value (STEL) has been derived for short-term effects. The SCOEL value was set at 2.6 mg/m3.
Data on repeated dose inhalation toxicity (90 day inhalation study on NO2) showed a NOAEC of 4.11 mg/m3, suggesting that the concentration of the substance rather than exposure duration is relevant for local toxicity of nitric acid. Therefore, the OEL of 2.6 mg/m3 can reasonably be used for short-term as well as long-term exposure of workers by inhalation.
In order to account for the additional components of the registered substance, the OEL of 2.6 mg/m3 is used for the substance itself, therefore introducing an added assessment factor. The components tin and citric acid are (based on the data available) considered of lower toxicity as compared to nitric acid (especially considering the composition reported in IUCLID Chapter 1.2), therefore this OEL represents a worst-case approach. For further information on the substance assessment, please refer to justification documentation attached in IUCLID Chapter 13.
This value is considered adequate to protect from any potential short-term or long-term systemic effects.
Due to the strong corrosive properties of the substance, the dermal route as well as effects on they eyes are covered in a qualitative approach, appropriate risk management measures are implemented.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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.
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