Registration Dossier

Administrative data

Description of key information

Minimally Toxic. Based on test data for the material.

Key value for chemical safety assessment

Additional information

Oral

Male and female rats were administered a single oral exposure (2000 mg/kg) of isotridecanol to assess the acute oral toxicity.  Clinical evaluations were made at 1, 2, 3, 5, and 24 hours post exposure and daily thereafter for 14 days.  All animals survived the exposure and the only adverse clinical effects were slight sedation and diarrhea noted a few hours after exposure.  These effects were resolved within 24 hours.  It is concluded that the LD50 is greater than 2000 mg/kg.

 

In a second study, male rats were exposed to isotridecanol at doses of 31.6, 100, 316, 1000, 3160, or 10000 ul/kg (26.7, 84.6, 267, 846, 2673, or 8460 mg/kg based on a density of 0.846) via oral gavage to assess acute toxicity.  One animal in the 2673 mg/kg group died on day 4 post exposure while 2 animals in the 8460 mg/kg group died within 4 hours post exposure, 2 more died within 2 days post exposure.  Adverse clinical signs from exposure included animals at the 846 mg/kg dosage level exhibiting depression characterized by inactivity and labored respiration.  However, these effects were resolved within 3days.  Immediately following dosing, the animals in the 2 highest dose levels exhibited depression characterized by inactivity, labored respiration, and ataxia; at the 1 and 4 hour interval, these animals also exhibited excessive urination and/or diarrhea.  In addition, the animals in the highest dose level exhibited sprawling of the limbs.  Most of these signs were resolved by day 4 post exposure unless death had occurred.  Based on these data, it is concluded that the LD50 is greater than 3160 ul/kg (2673 mg/kg).

 

Dermal

Ten rats were exposed to 2000 mg/kg body weight of isotridecanol via an occluded dermal patch for 24 hours to assess acute toxicity.  Clinical observations were made at 1, 2, 3, 5, and 24 hours and daily thereafter for 14 days.  All animals survived the exposure. It is concluded that the LD50 is greater than 2000 mg/kg.

 

In a second study, rabbits were exposed to isotridecanol at doses of 100, 316, 1000, or 3160ul/kg (84.6, 267, 846, or 2673 mg/kg based on a density of 0.846) for 24 hours.  Observation time points were at 1, 4, and 24 hours after application and once daily thereafter for 7 days.  At the end of the exposure period, the exposed skin areas showed moderate or marked erythema and mild or moderate edema, the degree being proportional to the dosage level tested.  In each animal the edema subsided within an additional 24 to 48 hours.  At the lowest dose level, noted erythema completely subsided within 48 hours while the remaining animals showed mild or moderate erythema at the time of sacrifice.  In addition, the exposed skin area of two animals at the highest level showed slight fissuring for several days.  During the last four or five days of the observation period, the exposed skin area of these animals generally showed mild or moderate atonia and/or desquamation.  All animals survived the exposure.  It is concluded that the LD50 is greater than 3160 ul/kg (2673 mg/kg).

 

Inhalation

Ten male mice, 10 male rats, and 10 male guinea pigs were exposed to a near-saturated vapor of isotridecanol for 6 hours.  The theoretical exposure concentration was 12.2 ppm.  During the exposure period all animals were observed for gross signs of toxicity every 30 minutes.  Thirty minutes after the initiation of the exposure, mice and rats exhibited blinking and redness around the nostril.  All animals appeared normal within 30 minutes after termination of the exposure.  No deaths occurred. It is concluded that the LC50 is greater than 12.2 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.