Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 632 mg/kg bw

Additional information

Oral

Male and female rats were administered a single oral exposure of 2000 mg/kg isooctanol and monitored for signs of acute toxicity daily for 15 days. This dose did not produce any mortality or any other adverse clinical signs of toxicity. It is concluded that the LD50 is greater than 2000 mg/kg.

 

In a second study, male rats were gavaged with isooctanol (31.6, 100, 316, 1000, 3160 or 10000 ul/kg as a 30% volume/volume emulsion in corn oil). Observations were made at 1, 4, and 24h post exposure and once daily thereafter for 7 days. All animals that received 3160 or 10000 ul/kg died within 4 hours of exposure. All other animals survived. Animals that died exhibited general signs of physiologic organ system depression before expiring.

 

Dermal

Rabbits were exposed to varying concentrations (100, 316, 1000, or 3160 ul/kg) of isooctanol via an occluded dermal patch for 24 hours. Observations were made at 1, 4, and 24 hours and daily thereafter for a total of 7 days. One animal in the highest dose group died within 24 hours of patch removal. All other animals survived. Within 4 hours of application, animals in the 3160 ul/kg exposure group exhibited signs of depressed physiologic function. All adverse observations were resolved within 2 days post exposure. It is concluded that the LD50 is greater than 3160 ul/kg (2632 mg/kg).

 

Inhalation

Groups of male mice, rats and guinea pigs were subjected to a whole body exposure of a nominal concentration of 24 ug/l of isooctanol as a saturated vapor for 6 hours. All animals survived the study. There were indications of depressed physiological function in all animals; indicated by sedation and labored breathing. These observations were resolved once the animals were moved into fresh air. From this study, it is concluded that the LC50 is greater than 24 mg/m3 as a 6 hour exposure.

 

In a second study, mice, rats, and guinea pigs were subjected to a 6 hour whole body exposure to 200 ppm isooctanol. All animals survived the exposure.  There were no adverse clinical signs observed during exposure. In this study, the LC50 is greater than 200 ppm.

Justification for classification or non-classification

No classification for acute toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.