Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 420: pre-GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960
Reference Type:
publication
Title:
Acute toxicity of a homologous series of branched chain primary alcohols
Author:
Scala RA and Burtis EG
Year:
1973
Bibliographic source:
Am Ind Hyg Assoc J 34:493-499

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
non standard doses
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11-iso-, C10-rich
EC Number:
271-234-0
EC Name:
Alcohols, C9-11-iso-, C10-rich
Cas Number:
68526-85-2
Molecular formula:
CnH2n+1OH (n = 9 to 11)
IUPAC Name:
Branched alcohols, C9-11, C10 rich
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Test material was mixed as 0.1, 1.0, 10.0 or 30.0% volume/volume emulsion in corn oil.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
31.6, 100, 316, 1000, 3160 or 10000 ul/kg (26.4, 83.8, 264, 838, 2648, or 8380 mg/kg respectively)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 4, and 24 hours and once daily thereafter for 7 days post administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Statistics:
No data analyzed

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD100
Effect level:
ca. 8 360 mg/kg bw
Remarks on result:
other: within 4 hours
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 648 mg/kg bw
Mortality:
None
Clinical signs:
At the 1 and 4 hour intervals the animals in the 316 and 1000 ul/kg dosage levels exhibited depression characterized by inactivity, labored respiration, ataxia, and sprawling of the limbs. At the 24 hour interval, many showed oily fur. Beginning with the second day following dosing, and daily during the remainder of the observation period, these animals exhibited normal appearance and behavior. At the 3160 ug/kg dose level, the animals appeared inactive and showed labored respiration, ataxia, and sprawling of the limbs at the 1 and 4 hour observation intervals. In addition, one animal showed lacrimation and depressed righting and placement reflexes. Except for oily fur at the 24 hour interval, all of these animals exhibited normal appearance and behavior throughout the remainder of the observation period. At the 10000 ul/kg dosage level, the animals exhibited inactivity, labored respirations, ataxia, and sprawling of the limbs, followed by a comatose state prior to death.
Body weight:
Not affected
Gross pathology:
Animals that died had congested lungs, kidneys, and adrenals, and dark-appearing spleens.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for isodecanol is >2648 mg/kg.
Executive summary:

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. LD50 is greater than 2648 mg/kg. At the end of the study, it was concluded that the LD50 >2648 mg/kg.