Registration Dossier

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
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
11.4
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 sulphuric acid that would warrant the use of an assessment factor of greater than 1 (the default).

Quality of the database:

The data available for sulphuric acid 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.