Reaction mass of 1-Propanaminium, 2,3-dihydroxy-N,N-dimethyl-N-[3-[(1-oxododecyl)amino]propyl]-, chloride and 1-Propanaminium, 2,3-dihydroxy-N,N-dimethyl-N-[3-[(1-oxotetradecyl)amino]propyl]- , chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

september 15, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Primary Dermal Irritation Test - 16 CFR 1500.41

Version / remarks:

Protocol 002/P201

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cocamidopropyl PG-dimonium chloride

Cas Number:

136920-08-6

Molecular formula:

C20-30H43-63ClN2O2 range

IUPAC Name:

Cocamidopropyl PG-dimonium chloride

Test material form:

other: aqueous solution

Details on test material:

Cocamidopropyl PG-dimonium chloride
Lot# D-273-36
Clear colorless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino

Details on test animals or test system and environmental conditions:

Healthy, USDA certified six New zealand Albino Rabbits from Davidson's MILL farm.
1 male and 5 females.
Rabbits were selected based on their skin condition and health status.
Acclimatation period: 14 days
Caging- individually in suspended stainless steel caging with mesh floors.
Room temperature 20-21C
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 sept 1, 1988, the test substance was applied to the intact and abraded test sites of each individual rabbit and occluded with adhesive-backed gauze patches secured in place with elastic wrapping

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hrs

Observation period:

Skin sites were evaluated at approximately 24 hrs and 72 hrs after initial exposure

Number of animals:

6 rabbits (1male / 5 females)

Details on study design:

six uniquely-identified rabbits were prepared by clipping the skin free of hair over approximately 10% of the body surface. Two test application sites, each approximately 2.5cm2 were delineated. One site was left intact, the other was abraded with a needle, taking special precaution not to penetrate the tratum corneum and not to cause bleeding. 0.5 mL of the test material was placed on each site and was immediately covered with 2x2-1/4 inch adhesive-hacked gauze patch. The patches and entire trunk of each rabbit were then wrapped with an elastic cloth to aid in maintaining test-patch position and to minimize evaporation. Neck collars were placed on each rabbit and the rabbits were returned to their individual cages. The neck collars and patches were removed after 24 hrs exposure at which time the test sites were gnetly wiped clean of any residual test material. Skin sites were evaluated at approximately 24 and 72 hrs after initial exposure and scoring according to 16 CFR 1500.41

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0.043

Remarks on result:

no indication of irritation

Remarks:

non-primary skin irritant

Irritant / corrosive response data:

All animal appeared healthy and active. There were no sign of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
One rabbit exhibited a slight erythema at the abraded site 24 hrs after dosing. This cleared by 72 hrs. No edema was observed at any time during the test period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

non-primary irritant according to FHSA dermal irritation test.

Executive summary:

To determine irritant and/or corrosive effects of a single 24 hr exposure of the test substance on the intact skin and abraded skin of rabbits.

A sample of cocamidopropyl PG-dimonium chloride was tested as received, undiluted.

After acclimatation to the lab, six healthy New Zealand albino rabbits were clipped free of haire over approximately 10% of their body surface. Two test sites, each approximately 2.5cm2, were delineated. One was left intact and one was abraded. 0.5 mL of the test material was placed on each site and occluded for 24hrs. The patches were then removed and the test sites were wiped to prevent further exposure. The test sites were evaluated 24 and 72 hrs after initial exposure.

All animal appeared healthy and active. There were no sign of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

One rabbit exhibited a slight erythema at the abraded site 24 hrs after dosing. This cleared by 72 hrs. No edema was observed at any time during the test period.

Summary scores and individual skin scores are available in the study report.

The Primary Dermal Irritation Index (PDII) was 0.043.

Based on scoring system used, the material is classified as non-primary skin irritant when applied as received, undiluted