Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
august 31, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Version / remarks:
Federal guidelines: pesticide assessment guidelines; Part 81-2 November 1984
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
Lot# HH105P
Cocamidopropyl PG dimonium chloride
Lexquat AMG-WC

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Sex:
male/female
Details on test animals and environmental conditions:
Healthy, USDA certified New Zealand albino rabbits were received from Davidson's Mill Farm, South Brunswick, NJ. Five male and five female rabbits were selected for test based on health status and body weight. The weight ranges for males and females were 2.5-3.4 and 2.3-2.5 kg respectively.

acclimatation period: 13, 49, 56, 66 days
Caging individually in suspended stainless steel caging with mesh floors
Temperature 20.5 - 22.7
Food: pelleted Purina Rabbit Chow ad-libitum
Water: tap-water supplied by automatic water system
identification: a number was allocated to each rabbit on receipt.
application day: on August 16, 1989, the test substance was applied to the test site of each individual rabbit and acculated with a non-permeable patch for 24 hrs.
Sacrifice and necropsy of survicors: August 30, 1989

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Following the adaptation period, 5 males and 5 females were prepared by clipping the skin free of hair over approximately 10% of the body surface (dorsal and ventral surfaces from scapular to pelvic area). A non-permeable adhesive-backed gauze patch containing 2g/kg bw of the test material (applied as received, undiluted) was placed over a 4-5 cm2 area on each rabbit. The patches and entire trunk of each rabbit were then wrapped with an elastic cloth to aid in maintaining test patch position to minimze evaporation. Neck collars were then placed on each rabbit. After 24 hrs of exposure to the test material, the patches and collars were removed and the exposed surface was gently wiped clean of any residual test material.
Duration of exposure:
24 hrs
Doses:
2 g/kg bw
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
The rabbits were observed for gross toxicity and mortality 1, 2, and 4 hours after test material application. Thereafter, they were observed at least once daily for the remainder of the 14-day test period.

Feed and water were provided ad-libitum thoughout the 14 day period. The body weight of each rabbit were recorded on the day of dosing, at 7 and 14 days post dosing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Body weight:
As of day 7, two rabbits lost weight. All others maintained their weights and gained slightly.
Gross pathology:
Erythema and edema were noted at all test sites 24 hrs after application of the test material. Thickening of the skin, discolorization and possible eschar were also noted during the 7 days following application.
several animals exhibited moist facial staining and several had reduced feed consumption and fecal output.
Observations are continuing until termination on day 14.

Applicant's summary and conclusion

Conclusions:
The Single Dose Acute Dermal Toxicity LD50 is greater than 2.0 g/kg bw when applied as received undiluted.
Executive summary:

To determine whether a single dose of 2 g of test substance per kg of bodyweight is toxic when applied dermally for 24 hrs to the skin of rabbits.

Following the adaptation period, 5 males and 5 females were occluded with 2g/kg bw of test material, applied as received, undiluted, for 24hrs. The rabbits were observed for gross toxicity and mortality 1, 2, and 4 hours after test material application. Thereafter, they were observed at least once daily for the remainder of the 14-day test period.

All animal survived. As of day 7, two rabbits lost weight. All others maintained their weights and gained slightly.

Erythema and edema were noted at all test sites 24 hrs after application of the test material. Thickening of the skin, discolorization and possible eschar were also noted during the 7 days following application.

several animals exhibited moist facial staining and several had reduced feed consumption and fecal output.

Observations are continuing until termination on day 14.

The Single Dose Acute Dermal Toxicity LD50 is greater than 2.0 g/kg bw when applied as received undiluted.