[No public or meaningful name is available]

Acute Toxicity: oral

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: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

yes

Remarks:

The first animal was dosed at 300 mg/kg, rather than a step below the estimated LD50 as indicated in the protocol; Systemic observations and a.m. mortality checks were not recorded for Animal 2/F on one day during the study; Animal 6/F was fasted only for

GLP compliance:

yes (incl. QA statement)

Remarks:

EPA 40 CFR parts 792 and 160, FDA 21 CFR 58

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): c-4000
- Physical state: liquid
- Analytical purity: >99%
- Purity test date: 2007-02-26
- Lot/batch No.: jyc0367
- Expiration date of the lot/batch: 2007-08-26
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

other: oral by syringe

Vehicle:

unchanged (no vehicle)

Doses:

300, 500 and 2000 mg/kg

No. of animals per sex per dose:

1 female animal dosed at 300 mg/kg
1 female animal dosed at 550 mg/kg
1 female animal dosed at 1750 mg/kg
5 female animals dosed at 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Toxicity and pharmacological effects: 1/2, 1, 2 and 4 hours postdose and once daily for 14 days
Mortality: twice daily
Body weight: immediately pretest, weekly and at termination
- Necropsy of survivors performed: yes
- Other examinations performed: Gross pathology. The contents of the abdominal and thoracic cavities were examined in situ for gross pathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived 300, 550, 1750 or 2000 mg/kg as a single oral dose

Clinical signs:

other: There were no abnormal physical signs noted during the observation period

Other findings:

Necropsy: four animals appeared normal at necropsy. Mottled kidneys and adrenals appearing larger than normal were noted in the rat dosed at 1750 mg/kg. Red areas on the thymus or a large red spot on the thymus were noted in two animals dosed at 2000 mg/kg. A red capsule (~2 mm) was found attached to abdominal fat in the animal dosed at 300 mg/kg; this finding does not appear to be due to the toxic effects of the test article. A bifurcated spleen was also noted in this same animal, however, this abnormality is probably not due to the toxic effects of the test article.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All animals survived 300, 550, or 2000 mg/kg as a single oral dose
The LD50 of C-4000 is greater than 2000 mg/kg in female rats
No classification needed for acute toxicity

Executive summary:

In an acute oral toxicity study, groups of eight healthy, non pregnant female Wistar albino rats were given a single oral dose of  c-4000 (>99%)at doses of  300, 550, 1750 or 2000 mg/kg bw and observed for 14 days.

 

Oral LD₅₀>2000  mg/kg bw

No mortality occurred. Limit test

C-4000 is of low Toxicity based on the LD₅₀in females.                                                                                

There were no major treatment related clinical signs, necropsy findings or changes in body weight.