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Description of key information

No information on animal testing of Doré on acute toxicity is available. The C&L of Doré 5 was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. Applying these rules, Doré 5 meets classification criteria for acute toxicity via ingestion but does not require classification as acutely toxic after skin contact and after inhalation. 
The converted acute toxicity point estimate value for acute toxicity, oral route is 500 mg/kg bw in accordance with EU CLP Guidance Annex I Table 3.1.2.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
5 000 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Substance specific information for the UVCB substance Doré as such is not available for the endpoint "Acute Toxicity". In order to meet the requirements for Annex VII - Annex X of Regulation (EC) 1907/2006, read across information from any constituent being relevant needs to be included. Due to the high number of constituents and variability in C&L of these constituents it was decided to use the classification information from the individual constituents and to calculate the resulting classification by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture” with the aid of the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

In total, five different grades of Doré (Doré 1 – Doré 5) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Thus, for Doré two C&L entries (i. e., no C&L and “harmful if swallowed”, respectively) for acute toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

The available information indicates that Doré composition profile 5 is harmful via ingestion, but not acutely toxic or harmful via the dermal route and by inhalation. Doré 5 requires classification as harmful if swallowed (Category 4) according to Regulation (EC) 1272/2008. Classification of Doré 5 for acute toxicity via the dermal and inhalation route is not required according to Regulation (EC) 1272/2008.

Specific target organ toxicant (STOT) - single exposure: oral, inhalation and dermal

The classification criteria according to Regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure are not met since no adverse health effects, including reversible and irreversible, were observed immediately or delayed after exposure.