Cetylpyridinium chloride

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

cetylpyridiunium chloride

IUPAC Name:

cetylpyridiunium chloride

Constituent 2

Reference substance name:

Cetylpyridinium chloride

EC Number:

204-593-9

EC Name:

Cetylpyridinium chloride

Cas Number:

123-03-5

Molecular formula:

C21H38N.Cl

IUPAC Name:

cetylpyridinium chloride

Constituent 3

Reference substance name:

CPC

IUPAC Name:

CPC

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 or test system 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:

other: 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 (ery

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.