Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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