9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium acetate

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:

data from handbook or collection of data

Justification for type of information:

Data is from secondary source

Data source

Reference

Reference Type:

other: Secondary source

Title:

Acute oral toxicity of test chemical in rats

Author:

USEPA

Year:

1992

Bibliographic source:

NTRL report, OTS0535826, 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

To determine the Acute oral toxicity study of test chemical in Rats.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride

EC Number:

201-383-9

EC Name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride

Cas Number:

81-88-9

Molecular formula:

C28H31N2O3.Cl

IUPAC Name:

9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride

Test material form:

solid: particulate/powder

Details on test material:

IUPAC name:9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
Mol. formula: C28H31ClN2O3
Molecular Weight: 479.017 gm/mol
Smiles: c1(c2c(oc3c1ccc(\c3)=[N+](/CC)CC)cc(N(CC)CC)cc2)c1c(cccc1)C(O)=O.[ClH-]
InChI: 1S/C28H30N2O3.ClH/c1-5-29(6-2)19-13-15-23-25(17-19)33-26-18-20(30(7-3)8-4)14-16-24(26)27(23)21-11-9-10-12-22(21)28(31)32;/h9-18H,5-8H2,1-4H3;1H

Specific details on test material used for the study:

No data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Rat pellets
- Water : Distilled water ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To:No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Maximum dose volume applied: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5000 mg/kg bw: 10 rats
Control: 10 rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined after 2 hours and daily for 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, mortality.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

Mortality observed

Mortality:

Death was observed in one animal at 48 hours and in a second animal at 72 hours.

Clinical signs:

other: All animals exhibited a mild to moderate lethargic response accompanied with ataxia, dyspnea, abnormal righting reflex, muscular weakness, piloerection and diarrhea. This condition persisted for approximately seventy-two (72) hours.

Gross pathology:

Gross pathology of survivors revealed that all target organs (heart. lungs, spleen. kidneys, liver and gastro-intestinal tract) appeared normal with the exception of a mild renal vascularization.

Other findings:

Autopsies of expired animals revealed hyperemic lungs, nephritic kidneys, peripheral lobular hemorrhage of the liver and hemorrhagic gastro-intestinal tract.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

In a acute oral toxicity study, the LD50 value was considered to be >5000 mg/kg bw when rats was treated with test chemical.

Executive summary:

The acute oral toxicity study was performed on rats to determine the toxic nature of the test chemical. 10 Sprague-Dawley rats were treated with test chemical at a concentration of 5000 mg/kg bw by oral intubation route. All animals exhibited a mild to moderate lethargic response accompanied with ataxia, dyspnea, abnormal righting reflex, muscular weakness, piloerection and diarrhea. This condition persisted for approximately seventy-two (72) hours. The average weight gain of the surviving test animals was 67.3 grams and that of control animals was 70.4 grams and the average weight loss of expired test animals was 19.0 grams. Gross pathology of survivors revealed that all target organs (heart. lungs, spleen, kidneys, liver and gastro-intestinal tract) appeared normal with the exception of a mild renal vascularization. Death was observed in one animal at 48 hours and in a second animal at 72 hours. Autopsies of expired animals revealed hyperemic lungs, nephritic kidneys, and peripheral lobular hemorrhage of the liver and hemorrhagic gastro-intestinal tract. Therefore based on the above observations, LD50 was considered to be >5000 mg/kg bw when 10 Sprague-Dawley rats were treated with test chemical orally.