Alcohols, C9-11-branched

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1960

Report date:

1960

Reference 2

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD100

Effect level:

ca. 8 360 mg/kg bw

Remarks on result:

other: within 4 hours

Effect levels 2

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.