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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January/24/2005- February/28/2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
TEST SUBSTANCE IDENTIFICATION: Cetylpyridinium Chloride
Lot #00217966
Purity: 100.1% by assay
TEST SUBSTANCE DESCRIPTION: White powder
DATE RECEIVED: January 12, 2005
PSL REFERENCE NO.: 050112-l

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Number of Animals: 10
Sex: 5 Males and 5 Females. Females assigned to test were nulliparous and non-pregnant.
Species/Strain: Rats/Sprague-Dawley derived, albino
Age/Body weight: Youngadult (l0-11 weeks)/males 301-330 grams and females 212-238 grams at experimental start.
Source: Received from Ace Animals, Inc., Boyertown, PA on January 25, 2005

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
65% (w/w) paste with water
Duration of exposure:
24 hours
Doses:
5000 mg/kg of body weight
No. of animals per sex per dose:
5 females and 5 males
Control animals:
no
Details on study design:
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 65% w/w mixture. 5000 mg/kg of body weight of the test substance was then applied to a 2-inch x 3-inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3
inches (approximately 10% of the body surface). The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.

Results and discussion

Preliminary study:
Preliminary sample preparation conducted by PSL indicated mixtures in excess of 65% (i.e., 70%-80%) were too dry to assure adequate skin contact.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths
Mortality:
All rats remained alive until euthanization
Clinical signs:
Following application, two females exhibited irregular respiration. However the affected females recovered by Day 2, and along with the other animals, appeared active and healthy for the remainder of the 14-day observation period. Dermal irritation (erythema, edema, hyperkeratosis, and eschar) was noted at the dose site of all animals between Days 1 and 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Body weight:
All animals survived exposure to the test substance and gained body weight.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of CPC is greater than 5,000 mg/kg of body weight in male and female rats.