Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The standard information requirements may be adapted when exposure is absent, not significant (Annex VI, Section 3.2 (a)(i); Annex VIII column 2 Section 8.6.1 and 8.7.1) or unlikely (Annex iV Column 2, Section 9.4) (ECHA 2011).The available data for PP796 indicate that the threshold concentration of the mode of action (induction of emesis) is lower than the threshold concentrations for the induction of adverse effects. Consequently, the phosphodiesterase inhibition of the substance restricts the in vivo exposure and occurrence of adverse effects, as adversity is not incurred at dose levels below the threshold for the induction of emesis. Thus, although the information requirements are fulfilled, the available data are considered unsuitable to derive a DNEL for systemic effects. Consequently, a qualitative assessment has been conducted for PP796.

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The standard information requirements may be adapted when exposure is absent, not significant (Annex VI, Section 3.2 (a)(i); Annex VIII column 2 Section 8.6.1 and 8.7.1) or unlikely (Annex iV Column 2, Section 9.4) (ECHA 2011).The available data for PP796 indicate that the threshold concentration of the mode of action (induction of emesis) is lower than the threshold concentrations for the induction of adverse effects. Consequently, the phosphodiesterase inhibition of the substance restricts the in vivo exposure and occurrence of adverse effects, as adversity is not incurred at dose levels below the threshold for the induction of emesis. Thus, although the information requirements are fulfilled, the available data are considered unsuitable to derive a DNEL for systemic effects. Consequently, a qualitative assessment has been conducted for PP796.

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

The phosphodiesterase inhibition of the substance restricts the in vivo exposure and occurrence of adverse effects, as adversity is not incurred at dose levels below the threshold for the induction of emesis. Thus, although the information requirements are fulfilled, the available data are considered unsuitable to derive a DNEL for systemic effects. In light of the mode of action, the absence of clinical signs in workers, such as nausea and vomiting, provide a sensitive marker of an absence of systemic exposure. For further information, please refer to the attached DNEL Report.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The standard information requirements may be adapted when exposure is absent, not significant (Annex VI, Section 3.2 (a)(i); Annex VIII column 2 Section 8.6.1 and 8.7.1) or unlikely (Annex iV Column 2, Section 9.4) (ECHA 2011).The available data for PP796 indicate that the threshold concentration of the mode of action (induction of emesis) is lower than the threshold concentrations for the induction of adverse effects. Consequently, the phosphodiesterase inhibition of the substance restricts the in vivo exposure and occurrence of adverse effects, as adversity is not incurred at dose levels below the threshold for the induction of emesis. Thus, although the information requirements are fulfilled, the available data are considered unsuitable to derive a DNEL for systemic effects. Consequently, a qualitative assessment has been conducted for PP796.

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

The derivation of DNELs is described in detail in the DNEL report attached to the technical dossier. The substance is added to plant protection products. The use of products containing the substance with the concerning active substance is prohibited in the EU, thus exposure of the general population is not relevant and DNELs do not need to be derived.