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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is reported in a 'Reclamed Substances Testplan' for Naphthenic acids in the frame of the High Production Volume Chemical Challende Program of US EPA and hence considered as secondary literature. Because no access to the original report was obtained a Klimisch score 4 for reliability has been assigned. However, this study has been evaluated by the American Petroleum Institute (API) and was found to be reliable without restriction. The following conclusion was drawn by the API: 'it appeared to be comparable to a guideline study with adequate experimental details provided. Although the investigators used male rats only, there is sufficient experimental detail to make a conclusion on the study's validity, and the results can be used to assess the potential acute toxicity of naphthenic acid.'

Data source

Referenceopen allclose all

Reference Type:
other: robust study summary
Title:
Unnamed
Year:
2003
Report date:
2003
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Male rats only
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthenic acids
EC Number:
215-662-8
EC Name:
Naphthenic acids
Cas Number:
1338-24-5
Molecular formula:
For the acidic (naphthenic) fraction: CnH2n+zO2, where n = carbon number and z = homologous group series number: z = 0 when no ring structures are present, z = -2 when 1 ring is present, z = -4 when 2 rings are present etc. For the non-acidic fraction: not applicable
IUPAC Name:
Naphthenic acids
Test material form:
liquid
Details on test material:
Physical state: Viscous liquid
Appearance: Pale yellow to dark amber

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
Rats were dosed at 1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10 g/kg of body weights.
No. of animals per sex per dose:
Seven groups of 5 male rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 1, 2, 4 and 6 hours ,after dosing and once daily for 14 days. Mortality, toxicity and pharmacological effects were recorded. Body weights were recorded pretest and in the survivors at 14 days.
- Necropsy of survivors performed: yes
All animals were examined for gross pathology

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5 880 mg/kg bw
Based on:
test mat.
95% CL:
>= 4.31 - <= 8.02
Mortality:
Deaths occurred at the four highest dose levels: 3.26, 4.64, 6.81 and 10 g/kg bw. 8/10 animals died at the two highest dose levels.
Clinical signs:
Significant predeath toxic signs included tremors, lethargy, ptosis, ataxia, prostration, negative righting reflex, flaccid muscle tone, piloerection, diarrhea, chromodacryorrhea. dyspnea and chromorhinorrhea. Body weight changes were noted in the survivors.
Body weight:
Body weight changes were noted in the survivors
Gross pathology:
Significant necropsy findings in the animals that died during the study included dilated hearts and gastrointestinal irregularities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be 5.88 (4.31-8.02) g/kg bw
Executive summary:

Seven groups of 5 male rats were dosed at 1.0, 1.47, 2.15, 3.16, 4.64, 6.81, and 10 g/kg of body weights. Mortality, toxicity and pharmacological effects were recorded. Body weights were recorded pretest and in the survivors at 14 days. At 14 days the survivors were sacrificed. All animals were examined for gross pathology.

Deaths occurred at the four highest dose levels: 3.26, 4.64, 6.81, and 10 g/kg bw. 8/10 animals died at the two highest dose levels. Significant predeath toxic signs included tremors, lethargy, ptosis, ataxia, prostration, negative righting reflex, flaccid muscle tone, piloerection, diarrhea, chromodacryorrhea, dyspnea and chromorhinorrhea. Body weight changes were noted in the survivors. Significant necropsy findings in the animals that died during the study included dilated hearts and gastrointestinal irregularities.

The LD50 was determined to be 5.88 (4.31-8.02) g/kg bw.