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

Endpoint summary

Description of key information

Acute Oral Toxicity: Key study >1000 mg/kg/day. Supporting study: >5000 mg/kg/day
Acute Dermal Toxicity: >2000 mg/kg/day.
Acute Inhalation Toxicity: Waiver based on relatively harmless levels of acute toxicity via the oral and dermal routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute – Oral

Key Study for Acute Oral In Vivo (Harlan Laboratories, 2010, OECD Guideline 423).

The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) was therefore >1000 mg/kg/day.

 

The supporting study by Leberco Laboratories in 1984 (EPA OPP 81-1) showed that the LD50 of Ebanol in rats was >5000 mg/kg.

Based on the available acute toxicity studies and supporting data there is no need to classify Ebanol in accordance with 67/548/ and 1272/2008/EC.

 

Acute – Inhalation

The oral and dermal LD50 levels for Ebanol have been determined and both demonstrate relatively harmless levels of acute toxicity >2000 mg/kg bw and therefore do not require labelling under CLP.

Testing by the inhalation route in accordance with column 2 of AnnexVIIIof 1907/2006/EC, is therefore considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.89 Pa at 25'C) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

 

Acute – Dermal

Key Study for Acute Dermal In Vivo (Harlan Laboratories - 2010).

The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

 

The acute dermal of Ebanol to rats at a dose level 2000 mg/kg/day produced no toxicologically effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) was therefore >2000 mg/kg/day.

Based on the available acute toxicity study data there is no need to classify Ebanol in accordance with 67/548/ and 1272/2008/EC. 

Justification for classification or non-classification

Justification for classification or non classification

Based on the oral LD50 value >1000 (supporting data >5000mg/kg) and dermal LD50 values >2000 mg/kg bw, there is no need to classify Ebanol for acute toxicity in accordance with the criteria outlines in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).