Registration Dossier
Registration Dossier
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EC number: 233-032-0 | CAS number: 10024-97-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 180 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: National OEL
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 18 000 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 360 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: National OEL
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL derivation for worker
Systemic effects after long-term exposure via inhalation
The literature database of nitrous oxide includes numerous epidemiological and animal studies but most animal toxicity studies have been done at high concentrations, usually using prolonged (continuous) exposures to characterise adverse effects of nitrous oxide and in some cases to investigate mechanisms of its toxicity. Therefore, only a few can be used for risk assessment purposes at the workplace and are included in the dossier.
Based on these data effects on pre- and postnatal development were identified as the most sensitive endpoint and a national occupational exposure limit (OEL) was derived by the German MAK commission.
A NOAEC of 10 000 ppm was derived for prenatal and postnatal developmental toxicity from studies in rats (Holson et al. 1995; Pope et al. 1978) and identified as the relevant starting point for the derivation of the OEL. By using an overall assessment factor of 100, a MAK value of 100 ppm (180 mg/m3) is established. Since the OEL has been set based on extensive human and animal data the use of the MAK value as the “Derived no effect level” for worker exposure is considered scientifically justified.
Systemic effects after short-term exposure via inhalation
There was no toxicological or occupational hygiene evidence that a brief excursion above the time-weighted average, as long as the 8-hour TWA OEL was observed, increased the health risk from exposure to nitrous oxide. Therefore, a peak limitation factor of 2 is applicable and a short-term DNEL for systemic effects of 360 mg/m3 can be derived.
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
