Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat) > 5000 mg/kg bw
Dermal LD 50 (rabbit) > 2000 mg/kg bw
Inhalative LD50 (rat) > 24880 mg/m³

Key value for chemical safety assessment

Additional information

Oral

 

There are no data available on the acute oral toxicity of octane. However, there are reliable data available for another category member. Thus, read-across was conducted based on a category-approach.

The acute oral LD50value in rats was greater than 5000 mg/kg for iso-octane (CAS No. 540-84-1). Clinical observations noted one-hour post exposure in 8 of 10 animals included depression, salivation, wheezing, rough coat, and soft faeces. Two female rats appeared normal throughout the study. All animals appeared normal from day 2 through termination of the study (Chevron Phillips, 1982).

 

Inhalation

 

Ten male and female Sprague-Dawley rats were exposed to octane via whole body inhalation at nominal concentration of 24880 mg/m³ for 4 hours (similar to OECD 403). The analytical concentration was determined to be ca. 99500 mg/m³. There was no mortality during the course of the study. After 15 min of exposure all animals displayed rapid breathing. At 30 min of exposure one male and all females showed tremors and hyperactivity. At one hour these animals became languid with tremors. All animals then were noted to be inactive with rapid respiration for the duration of the exposure. Normal appearance was observed for all animals at day 1 and subsequently through the 14-day observation period. The LC50was greater than the nominal concentration of 24880 mg/m³ (Chevron Phillips, 1983).

 

Dermal

 

There are no data available on the acute dermal toxicity of octane. However, there are reliable data available for another category member. Thus, read-across was conducted based on a category-approach. The dermal LD50value of iso-octane (CAS No. 540-84-1), as determined in rabbits, was greater than the limit dose of 2000 mg/kg. All rabbits appeared normal throughout the study. Very slight dermal erythema was noted in all animals on day 1 after dosing, which persisted in one male and one female on day 3. All erythema had cleared by day 7. Very slight oedema was noted in two males and one female on day 1 and cleared by day 3. Epidermal scaling was noted in one female on day 10 (Chevron Phillips, 1982).

Justification for classification or non-classification

The available data on the acute toxicity of octane as well as structurally related substances are conclusive but not sufficient for classification. However, acute inhalative exposure may result in non-lethal narcotic effects and, as a hydrocarbon, it poses aspiration hazard.

 

DSD: R65-67

 

CLP: Aspiration Toxicity Category 1, STOT Single Exposure Category 3 (narcosis)