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Administrative data

Description of key information

Oral LD50 > 10000 mg/kg b.w.

Dermal LD50 > 2500 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Lack of exposure concentrations, only indication of mortality and necropsy findings after exposure time.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

No studies on "Acute toxicity" are available for the Target Substance, therefore information on Similar Substance 01 and 02 have taken into account for the assessment. Details on the similarity between the Target Substance and the Similar Substances are reported in section 3.

Acute toxicity was assessed through oral, dermal, inhalation and intraperitoneal route of exposure.

Acute toxicity: oral

Two studies were considered in order to complete the assessment on Acute oral toxicity: One test was conducted on Similar Substance 01 but limited information is available regarding the method and the experimental results. Therefore, another test conducted on the Similar Substance 02 was considered in order to confirm the results of the first test.

The two results are consistent (LD50 > 10000 mg/kg bw and LD50 > 2000 mg/kg bw) and the substance is expected to have an LD50 > 2000 mg/kg bw.

Acute toxicity: inhalation

In the study conducted on Similar Substace 01, no deaths occurred at the highest exposure time of 8 hours, however, no indication regarding the exposure concentration was present. For this reason, the performed study is not suitable for classification purpose.

Acute toxicity: dermal

Rats were exposed to a single dermal application of the test substance (Similar Substance 01). After 14 days of observation, no deaths occurred and no abnormalities were noted at necropsy.

Other sudies on Similar Substance 01 are available on another route of exposure (intraperitoneal) and were reported in the endpoint nevertheless, no indication on classification can be derived.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), for both oral and dermal route the substance does not meet the criteria for classification, since the determined LD50 values is above the threshold values of 2000 mg/kg b.w.

Regarding the inhalation route, despite the available study did not reported the actual concentration of the substance in the inhaled air, the negligible vapor pressure of the substance and its physical state does not suggest inhalation route as potential hazard. Furthermore, since the lower range of the particle size distribution is ca. 11 µm, the respirable fraction should be extremely low.