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Toxicological information

Acute Toxicity: oral

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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:
other: 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 th
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.