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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report contains limited information, pre-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Versatic 10
- Substance type: liquid
- Analytical purity: assumed 100%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1, 1.5, 2, 3, or 4 ml/kg
No. of animals per sex per dose:
4 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days post dosing
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights
Statistics:
LD50 value and 95% confidence intervals were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 066 mg/kg bw
95% CL:
>= 1 693 - <= 2 530
Mortality:
Animals that died did so within 3 days post exposure.
Clinical signs:
Lethargy, hypothermia, piloerection, dyspnea, ataxia
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

4 Animals per sex per dose group

Daily Mortality
Dose ml/kg 1 2 3
M F M F M F
1
1.5
2 3 1 1
3 2 1 1 1
4 1 4 3

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 is approximately 2.27 ml/kg (2066 mg/kg).
Executive summary:

In this study, male and female rats were gavage with neodecanoic acid at concentrations of 1, 1.5, 2, 3, or 4 ml/kg. All animals that died during the study did so within 3 days of exposure. Signs of toxicity included lethargy, hypothermia, piloerection, dyspnea, and ataxia. Based on these results, it is concluded that the LD50 is approximately 2.27 ml/kg (2066 mg/kg).