Registration Dossier
Registration Dossier
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EC number: 201-084-3 | CAS number: 78-11-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 220.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEC
- Modified dose descriptor starting point:
- NOAEC
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
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
Derivation of DNEL according to REACH guidance
According to REACH guidance, the use of a number of assessment factors need to be considered when deriving the DNEL. These include factors for interspecies differences, intraspecies differences, duration of exposure, dose-response and the quality of the database. These assessment factors have been used for the derivation of a DNEL for pentaerythritol pentanitrate is considered in turn:
Correction of starting point:
The NOAEC of 2500 mg/kg bw/day should be corrected for the duration of exposure (6 hours/day in the study) to 8 hours (relevant for worker exposure) since the starting point and also for breathing rate (6.7 m3/10 m3), relevant for workers potentially exposed for 8 hours/day. The corrected inhalatory NOAEC is 4408 mg/m3.
Interspecies differences:
For local irritant effects differences in toxicodynamic factors are not relevant, however a default factor of 4 is recommended to cover possible differences in regional airflow and deposition.
Intraspecies differences:
A default assessment factor of 5 is recommended in the REACH guidance for workers for systemic and local effects in the absence of specific information.
Differences in duration of exposure:
The use of various assessment factors is discussed when deriving DNEL values relevant to long-term exposure from studies of shorter duration. In addition, the available data do not indicate any significant differences resulting from different exposure periods. A lower assessment factor of 1 can therefore be used in this case.
Dose-response relationship:
There are no specific concerns for pentaerythritol tetranitrate that would warrant the use of an assessment factor of greater than 1 (the default).
Quality of the database:
The data available are comprehensive. The use of a default assessment factor of 1 is therefore appropriate.
Using the NOAEC of 4408 mg/m3as the point of departure and applying an overall assessment factor of 20 results in a DNEL of 220.4 mg/m3.
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
Significant inhalation, dermal or oral exposure of the general population is not predicted; DNEL/DMEL values are therefore not proposed.
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