Registration Dossier

Administrative data

Description of key information

The test item did not cause mortality or signs of acute intoxication in male rats that received a single oral dose of 10000 mg/kg body weight or in male rabbits that received a single dermal dose of 10000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 000 mg/kg bw

Additional information

The test item did not cause mortality or signs of acute intoxication in male rats that received a single dose of 10000 mg/kg body weight. The study was performed prior to the introduction of GLP and OECD testing guidelines. Its design is comparable to that of OECD testing guideline 423. No adverse findings were recorded upon necropsy that was performed at the end of the 14-day post-observation period.

Octabenzone did not cause mortality or signs of acute intoxication upon dermal application of 10000 mg/kg body weight to five male rabbits. The study was performed prior to the introduction of GLP and OECD testing guidelines. Its design is comparable to that of OECD testing guideline 402, with deviations in species and observation period. The substance was applied as an aqueous paste which was held in continuous contact with shaved rabbit skin for 24h. After exposure, rabbits were observed for 7 days. No effects on body weight and no findings upon necropsy were observed.

No experimental data is available regarding acute inhalation toxicity.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.