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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:
3 160 mg/kg bw

Additional information

Oral

Isodecanol was administered via oral gavage to 5 male rats at doses of 31.6, 100, 316, 1000, 3160 or 10000 ul/kg (26.4, 83.8, 264, 838, 2648, or 8380 mg/kg respectively) to assess acute oral toxicity.  Clinical observations were made at 1, 4, and 24 hours and daily thereafter for 7 days post exposure. All animals in the 10000 ul/kg (8380 mg/kg) dose group died within 4 hours of exposure. All other animals survived, but exhibited signs of depression at 4 hours; characterized by inactivity, labored respiration, ataxia, and sprawling of the limbs. At 24 hours, the animals that survived appeared to be acting normally. At the end of the study, it was concluded that the LD50 >2648 mg/kg.

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 on isotridecanol, 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

Isoundecanol was administered via an occluded dermal patch to 5 each of male and female rabbits at the limit dose of 3160 mg/kg for 24 hours.  Dermal evaluations occurred at 2 and 4 hours post patch removal and once daily thereafter for 14 days.  At the end of the study, no animals succumbed to the dose, the dermal LD50 >3160 mg/kg.

 

Inhalation

Isodecanol was administered as a vapor to 10 male mice, rats, and guinea pigs at the theoretical concentration of 95.3 ppm for 6 hours.  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; eventually signs of nasal discharge and salivation were observed and persisted throughout the experiment.  All animals appeared normal within 30 minutes after termination of the exposure.   At the end of the study, the LC50 was > 95.3 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.

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