A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]

Endpoint summary

Description of key information

Acute oral toxicity: LD50 is >2000 mg/kg bw in an OECD TG 401. 

Acute toxicity inhalation: LC50 is >5200 mg/m^3 (route to route extrapolation).

Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The one acute oral toxicity study available is of sufficient quality for the present dossier.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute inhalation toxicity is derived using route to route extrapolation from the acute toxicity results, using 100% absorption. This assessment is considered to be sufficiently adequate for covering this endpoint.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The one acute dermal toxicity study available is of sufficient quality for the present dossier.

Additional information

Acute oral toxicity

The substance was tested in an acute oral toxicity test (OECD TG 401). A limit dose of 2000 mg/kg bw was used as a preliminary study indicated that the acute lethal oral dose to male and female rats of the substance was greater than 800 mg/kg bodyweight. In the main study, no mortality occurred at 2000 mg/kg bw. Pilo-erection was observed in all animals within three minutes of dosing and throughout the remainder of day 1. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was complete by day 2. All animals showed expected bodyweight gain. No macroscopic abnormalities were observed. The LD50 resulted in >2000 mg/kg bw.

Acute inhalation toxicity

No data on acute inhalation toxicity of the substance is available and are not needed because an acute oral and dermal toxicity study are available. The acute inhalation toxicity for the substance can be derived using data on the acute oral toxicity using the following methodology: The LD50 of the substance is > 2000 mg/kg bw, the highest dose tested. The 2000 mg/kg bw can be converted to 5200 mg/m^3. Taking into account that the absorption during inhalation route can be twice as high as during oral absorption. The maximum saturated vapour pressure for this substance is 144 mg/m3 (1.5 Pa x 234000 MW (mg/Mol)) / (8.3 (R, gas constant) x 293K). The LC50 value of > 5200 mg/m3 cannot be reached because of this saturated vapour concentration. On this basis, acute inhalation toxicity is not anticipated. 

Acute dermal toxicity

The substance has been tested in an Acute Dermal Toxicity test (OECD TG 402) at a limit dose of 2000 mg/kg body weight. No mortality was observed and there were no signs of systemic toxicity. Slight erythema with no oedema was observed at the sites of application of the test substance for all animals on day 2 only. This was accompanied by a residual (brown) staining from the substance at all treatment sites on days 2 to 6. There were no other dermal changes. Slightly low bodyweight gains were recorded for all five males and two females on day 8 and in four males and one female on day 15; in addition, no change in bodyweight or a slight bodyweight loss were recorded in two females on day 8. These findings were associated with the treatment procedure. No abnormalities were noted at necropsy. The acute dermal LD50 was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity according to EU CLP (EC No. 1272/2008 and its amendments).