Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute Toxicity:
- oral: LD50 5300 kg/kg bw (mouse)
- dermaL. LD50 > 2000 mg/kg bw (rat; analogy mixed isomers, CAS 8013-90-9)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
5 300 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Additional information

To test for acute oral toxicity, pure beta-ionone was administered to a group of five mice at three dose levels. The resulting LD50 was 5300 mg/kg bw.

Furthermore, oral toxicity was evaluated in a 5-day test, where doses of 500, 1000, 2000, 4000 and 8000 mg/kg bw were administered to rats (Hoffmann-LaRoche, 1975). No mortality was observed up to a dosage of 2000 mg/kg bw, but higher doses showed lethality. As a clinical sign of toxicity, sedation was described at dosages of 500 mg/kg bw or higher. Because 40% of the animal at the 4000 mg/kg dose group died after 5 applications within the 15 day period, one could assume that fewer animals would have died after only one application. Thus, the LD50 for rats was estimated as >4000 mg/kg bw.

To support this low acute oral toxicity, studies with the beta-ionone isomer (CAS 14901 -07 -6) are used. In a study with rats, deaths occurring within 24 h and within 10 days after dosing were recorded (Givaudan, 1980). The calculated LD50 was 7120 +/- 1000 mg/kg bw for deaths within 24 h and 3290 +/- 500 mg/kg bw after 10 days. In the same study, the LD50 for acute oral toxicity in mice was found to be 2000 +/- 320 mg/kg bw after 10 days of observation. In another study with male mice, the LD50 was found to be 5331 +/- 755 mg/kg bw (Hoffmann-LaRoche, 1967).

Due to the lack of data for acute dermal toxicity, results from the mixed iosmers (CAS 8013 -90 -9) are taken into account. In an OECD 402 -study (Symrise, 1999) 10 Sprague Dawley rats (5/sex) had their fur clipped on their backs and flanks. 2000 mg/kg bw of undiluted test substance was applied and covered with gauze. After 24h the area was wiped to removed the test material. All animals survived to the end of the 14 -day observation period, the LD50 was found to be >2000 mg/kg bw.

Because of the structural similarities the same result for beta-ionone (CAS 79 -77 -6) has to be expected.

Justification for classification or non-classification

Due to the resulting LD50 values for acute oral and acute dermal toxicity of 5300 mg/kg bw and >2000 mg/kg bw, respectively, no classification is required.