Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005/01/12-2005/05/27
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 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)

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-ID
Study Initiation Date: January 24, 2005

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals and environmental conditions:
Housing: The animals were singly house in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature Range: 19-22C.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 21 Days
Food: Pelleted Pruina Rabbit Chow # 5326 ad libitum. Water supplied ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g of test material; (moistened with water, so 0.77g of the test mixture)
Duration of treatment / exposure:
4 hours
Observation period:
14 days.
Number of animals:
3 rabbits
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. Five-tenths of a gram of the test substance (0.77g of the test mixture) was placed on a 1 -inch by 1 -inch, 4 ply gauze pad and applied to one 6 -cm^2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 -inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their disignated cages.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 days
Score:
4.9
Max. score:
8
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
Within 24 hours of patch removal, all three treated sites exhibited moderate to severe erythema and slight edema. Although the overall serverity of irritation gradually decreased, dermal irritation (erythema, edema, desquamation, and/or superficial eschar) persisted for all animals through Day 14.
Other effects:
No clinical signs or evidence of systemic toxicity.

Any other information on results incl. tables

Moderately irritating.

(PDII): PDIfor1, 24, 48 and 72 hours= 4·9

4

 

 

Hours

Days

1

24

48

72

7

10

14

Erythema

3.0

3.0

3.0

3.0

3.0

2.3

1.7

Edema

1.7

2.0

2.0

2.0

2.0

1.3

1.3

TOTAL(PDI)2

4.7

5.0

5.0

5.0

5.0

3.6

3.0

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CPC is classified as moderately irritating to the skin, with a PDII of 4.9.