Registration Dossier

Administrative data

Description of key information

Oral LD50 (rat) > 2000 mg/kg bw
Dermal LD50 (rat) > 2000 mg/kg bw
Acute toxicity: Inhalation: waiver

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

In an acute oral toxicity GLP study according to OECD 423, one group of three male and three female HanBrl:WIST (SPF) rats was treated by oral gavage with Y-15099 at 2000 mg/kg bw (Damme, 2001). The test item was applied undiluted in a volume of 2 mL/kg bw. The observation period was 15 days. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The acute oral LD50 was found to be greater than 2000 mg/kg bw.

 

Acute dermal toxicity: 

In an acute dermal toxicity GLP study according to OECD 402, groups of five male and five female Hanlbm:WIST (SPF) rats were treated with undiluted Y-15099 at 2000 mg/kg bw by dermal application under semi-occlusive conditions (Damme, 2001). The exposure duration was 24 hours. The animals were observed for 15 days. No deaths occurred during the study. No clinical signs of toxicity and no macroscopic pathological changes were observed. The acute dermal LD50 was found to be greater than 2000 mg/kg bw.

 

Acute inhalation toxicity:

According to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5.2, Column 2, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of the liquid substance is very low (0.002 Pa at 25 °C).Exposure to vapour can thus be precluded. Exposure to droplets is not given for the determined uses of the substance.

 

Justification for classification or non-classification

The inhalation route was judged to be a non-relevant route of exposure.

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute toxicity, no classification is warranted.