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Administrative data

Description of key information

Acute oral toxicity (OECD TG 423): LD50 > 2000 mg/kg bw trans-rose oxide (Symrise, 2001)
Acute dermal toxicity: LD50 > 5000 mg/kg cis-rose oxide (Moreno 1973); LD50 > 2000 mg/kg bw dihydro-rose oxid (BASF 1984; 83/186)

Key value for chemical safety assessment

Additional information

Acute oral toxicity.

In the key study, acute oral toxicity is assessed according to OECD TG 423, using groups of ten Sprague Dawley rats (5 per sex) after administration of a single oral dose of the single stereoisomer trans - rose oxide (CAS 4610-11-1) at a dose level of 2000 mg/kg body weight. One of 5 female rats died within 7 days. No mortality occured in the male rats. No mortality was observed in 3 rats/ sex after administration of 200 mg/kg bw rose oxide. Under the conditions of this study the LD50 was found to be above 2000 mg/kg bw (Symrise, 2001). In a supportive study with limited documentation, an acute oral toxicity of the stereoisomer cis-rose oxide (CAS 3033 -23 -6) in rats, the LD50 was reported to be 4300 mg/kg bw (Moreno 1973).

Acute dermal toxicity.

In a dermal toxicity study with the stereoisomer cis-rose oxide (CAS 3033-23-6), no mortality was observed in 3 rabbits, resulting in an LD50 > 5000 mg/kg bw (Moreno 1973). These results are supported by a further study done with the structurally similar dihydro-rose oxide (CAS 13477-62-8). Acute dermal toxicity was assessed using 10 Wistar rats (5/sex) after administration of a single semiocclusive dermal dose of dihydro rose oxide at a dose level of 2000 mg/kg bw for 24 hours. Since no substance related deaths and no systemic effects occured the LD50 was defined to be greater than 2000 mg/kg bw (BASF 1984; 83/186). In a weight of evidence, rose oxide is considered to show no acute dermal toxicity.

Acute inhalative toxicity.

In light of the accumulated study results on the test substance rose oxide from acute oral and dermal toxicity studies, and the fact, that acute toxicity data on a second and human relevant route of exposure are available, an acute toxicity study via the inhalative route is scientifically not required and is not in line with animal welfare requirements.

The reasons for the present data waiving is based on the following study results:

-  Acute oral toxicity study revealed a LD50 > 2000 mg/ kg bw (Symrise, 2001)

-  Acute dermal toxicity study revealed a LD50 > 5000 mg/ kg bw (Moreno, 1973)

- Acute inhalative hazard test done with a structurally simliar substance (dihydro-rose oxide, CAS 13477-62-8) showed no mortality in rats after exposure to an vapor saturated atmosphere for 7 hours (BASF, 10I0358/927012). Overall, the acute inhalative toxicity of rose oxide is considered to be low.

Justification for classification or non-classification

The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted. According to UN-GHS, the test substance needs to be classified as acute oral toxicant (Category 5).