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Diss Factsheets

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:
1968
Report date:
1968
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

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.