[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Dermal observations were not recorded on Days 11 and 12 of the study.

GLP compliance:

yes

Remarks:

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

Test type:

standard acute method

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: ambient temperature and humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: covered with an impervious cuff and plastic lined elastic bandage secured with adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with paper towels saturated with tap water and blotted dry with dry paper towels
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 (five)

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, and 4 hours postdose and once daily thereafter for 14 days
Signs of erythema and edema: daily
Mortality: twice daily
Body weights: 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:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All ten animals survived

Clinical signs:

other: Instances of diarrhea, wetness and soiling of the anogenital area and few feces were observed during the study

Gross pathology:

Erythema, brown areas and flaking skin were noted in the females through Day 5. No abnormal dermal effects were noted in females after Day 5

Other findings:

Necropsy reveled slightly motteld kidneys in one female, otherwise, the animlas appeared normal at necropsy

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The dermal LD50 of C-4000 is greater than 2000 mg/kg of body weight in rats
No classification needed for acute dermal toxicity.

Executive summary:

In an acute dermal toxicity study, five Wistar Albino rats per sex per dose were dose dermally with C-4000 (>99%)at 2000 mg/kg bw and observed for 14 days.

 

Dermal LD₅₀>2000  mg/kg bw

No mortality occurred. Limit test

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

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