Naphthenic acids

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

other: robust study summary

Title:

Unnamed

Year:

2003

Report date:

2003

Reference 2

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

Test material information

Constituent 1

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:

11-(decahydronaphthalen-2-yl)undecanoic acid; 11-cyclopentylundecanoic acid; 15-cyclohexylpentadecanoic acid; 3-(tetradecahydroanthracen-2-yl)propanoic acid; 4-(tetradecahydroanthracen-2-yl)butanoic acid; 7-(tetradecahydroanthracen-2-yl)heptanoic acid; 9-(octahydropentalen-2-yl)nonanoic acid; dodecahydro-1H-phenalene-1-carboxylic acid

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:

other: 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 survivo

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.