Alcohols, C8-10-iso-, C9-rich

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:

1968

Report date:

1968

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1973

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:

no

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

- Substance type: Commercial product
-Molecular weight: 144.25

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

No information provided.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% volume per volume

Doses:

34.6, 120, 417, 1450, 5000, and 10000 mg/kg body weight

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 for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

No data analyzed.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 979 mg/kg bw

95% CL:

>= 1 108 - <= 8 010

Remarks on result:

other: Estimated from data

Mortality:

- 100 % mortality in the 10000 mg/kg group within 24 hours of exposure.
- 3 of 5 animals died in the 5000 mg/kg dose group within 2 days post exposure.
- All other animals survived until study termination

Clinical signs:

other: None

Gross pathology:

Discolored lungs and kidneys

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of isononanol is approximately 2979 mg/kg.

Executive summary:

Isononanol was administered via oral gavage to 5 male rats at doses of 34.6, 120, 417, 1450, 5000, and 10000 mg/kg to assess the acute oral toxicity.  Clinical observations were made at 1, 4, and 24 hours and once daily for 14 days post exposure.  All animals died within 24 hours post exposure in the 10000 mg/kg dose group.  Three of 5 animals in the 5000 mg/kg dose group died within 48 hours of exposure.  Based on the results of this study, the estimated LD50 is 2979 mg/kg.