Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
22 January 1985 - 5 February 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study was performed under GLP but not according to standardized guidelines. Methods were comparable to OECD 402 guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method: other: Pesticide Assessment Guidelines, EPA , 540/9-82-025
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Label: KETJENSEPT TC 500 gram
Received From: R.W. Greeff & Co., Inc. 901 Dove Street, Suite 228 Newport Beach, California 92660
Date Received: December 17, 1984
Quantity Received: 1 kilogram
Physical Description: Fine white powder
Storage: Room temperature
Density: 1.05 g/ml (8.00% w/v dilution)
Purity and Composition: Not provided by sponsor
Stability: Not provided by sponsor
Concentration Administered: 8.00% w/v concentration in deionized water

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: young adult
- Weight at study initiation: 2.825 - 3.550 kilogram
- Fasting period before study: No, not applicable
- Housing:
Cage Type: Suspended wire bottom galvanized steel
Housing: Individually
Transfer to Clean Cages: Weekly
Litter Pan Lining: Paper
Litter Pan Lining Change: Daily
- Diet (e.g. ad libitum): ad libitum, Food: Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum, Water Type: Tap
- Acclimation period: at least one week

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: 22 January 1985 - 5 February 1985

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- % coverage: ≥ 10%
- Type of wrap if used: Surgical gauze (two layers thick) was applied to the trunk of the animal and held in place with a non-irritating adhesive tape to keep the test matzrial in contact with the skin of the exposure area. The entire trunk of each animal was then wrapped with a semi-permeable material (Tomac Tubular Stockinette). The semi-permeable wrappings were secured in place with a non-irritating adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The wrappings, tape, and gauze were removed from the animals and the exposure areas were gently washed with room temperature tap water to remove as much remaining test material as possible.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.92 ml/kg
- Concentration (if solution): 8% w/v
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable
Duration of exposure:
24 hours
Doses:
2020 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for pharmacologic and/or toxicologic effects and mortality were made at 1/2, 3, and 6 hours after treatment and at least once daily thereafter for fourteen days (day of treatment considered Day 0). Individual body weights were recorded on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: -
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 mg/kg bw
Remarks on result:
other: calculated back to the active ingredient the LD50 is > 153.6 mg/kg bw
Mortality:
No mortality observed after 24 hours of exposure.
Clinical signs:
Decreased activity, decreased defecation, and no urination.
Body weight:
No effects observed
Gross pathology:
No abnormalities observed. 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute dermal LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 2020 mg/kg (1.92 ml/kg) when applied as a 8.00% w/v concentration in deionized water to the intact skin of albino rabbits. Calculated back to the pure test material the LD50 for the active ingredient is > 153.6 mg/kg bw . Therefore this study is not suitable for classification purposes but does give an indication of the LD50.
Executive summary:

An acute dermal toxicity study was conducted on male and female albino rabbits using test material KETJENSEPT TC 500 gram (hereafter referred to as KETJENSEPT TC). The test material was administered as a 8.00% w/v concentration in deionized water. This study was designed and performed in STILLMEADOW, Inc.'s AAALAC accredited laboratory under Pesticide Assessment Guidelines promulgated by the U.S. Environmental Protection Agency (EPA Publication 540/9-82-025) and was in compliance with Good Laboratory Practice Standards (Fed. Reg. 48, 53946, 1983).

Five male and five female albino rabbits were selected for testing. The exposure areas were treated with 2020 mg/kg of test material (1.92 ml/kg of a 8.00% w/v concentration of the test material in deionized water) and were then occluded for twenty-four hours. No animals treated with KETJENSEPT TC died during the study. The acute dermal LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 2020 mg/kg (1.92 ml/kg) when applied as a 8.00% w/v concentration in deionized water to the intact skin of albino rabbits. Calculated back to the pure test material the LD50 for the active ingredient is > 153.6 mg/kg bw .

Therefore this study is not suitable for classification purposes but does give an indication of the LD50.