3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

Endpoint summary

Description of key information

A OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) was performed to GLP, a synopsis is given below.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) Oral Study:

Conclusion.

The oral administration of Ebanol to rats by gavage, at dose levels of 1000, 325 and 35 mg/kg/day, resulted in non-adverse treatment-related effects in animals of either sex from all treatment groups.

 

Some liver and thyroid changes together with associated organ weight changes detected were considered to be adaptive in nature and do not represent an adverse effect of treatment. The kidney changes identified in males at 1000 mg/kg/day were consistent with well documented changes and are peculiar to the male rat in response to treatment with some hydrocarbons. This effect is, therefore, not indicative of a hazard to human health.

 A No Observed Effect Level (NOEL) was not absolutely established. However, the clear No Observed Adverse Effect Level (NOAEL) for either sex was considered to be 1000 mg/kg/day.

Waiver for inhalation toxicity:

In line with Column 2, point 8.6.1, Annex VIII of Regulation 1907/2006, a repeat-dose inhalation study does not need to be performed as the substance has low vapour pressure and high melting point, so the potential for the generation of inhalable forms is low. The use of this substance should not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and a repeat-dose inhalation study is not required. As an objective of Regulation EC No. 1907/2006 is to reduce, replace or refine animal testing, based on the above information and information in this dossier, it can be reasonably expected that inhalation exposure is not expected and as such, it is not warranted to test the hypothesis in animals.

Waiver for dermal toxicity:

The physicochemical and toxicological properties suggest low potential for significant rate of absorption through the skin. Furthermore the results of laboratory animal studies show low acute dermal toxicity. In the 28 - days repeated dose study via dietary administration does not exacerbate systemic toxicity effects which suggest bioavailability is low, thereby there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration.

Justification for classification or non-classification

According to Directive 67/548/EEC and Regulation (EC) 1272/2008, no classification is warranted.