Trimethyl-3-[(1-oxoallyl)amino]propylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch Test for Primary Skin Irritation and Corrosivity (Code of Federal Regulations, Title 16, Chapter II, 1976) and Section 173.240 of the department of Transportation Hazardous Materials Regulations ( Federal Register, Monday, September 27, 1976)

Principles of method if other than guideline:

.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diallyldimethylammonium chloride

EC Number:

230-993-8

EC Name:

Diallyldimethylammonium chloride

Cas Number:

7398-69-8

IUPAC Name:

N-allyl-N,N-dimethylprop-2-en-1-aminium chloride

Details on test material:

- Name of test material (as cited in study report): CC-47 DADMAC monomer
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: pale yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml undiluted

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Six

Details on study design:

0.5 ml of undiluted test material was applied under a one inch square surgical gauze patch to an intact and abraded skin on both the back and abdomen of 6 New Zealand White rabbits. Each patch was held in place by 2 one inch strips of adhesive tape. After application of the patches, the trunk of each rabbit was wrapped with rubber dental damming which was secured with staples. After 24 hours, the patches were removed and any residual material was removed. The reactions were scored immediately after the removal of the patches (24-hour reading) and again 48 hours later (72-hour reading).

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

> 0.04 - <= 0.09

Max. score:

8

Reversibility:

no data

Irritant / corrosive response data:

Following dorsal application, irritative effects noted at the 24-hour reading included very slight erythema at one intact and one abraded site. The Primary Irritation Index (PII) was found to be 0.09. Following ventral application, no irritative effects were noted at the 24-hour reading. However, at the 72-hour reading, very slight erythema was noted at one abraded site. No other irritative effects were noted at any time throughout the study. The Primary Irritation Index (PII) was found to be 0.04.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DADMAC was determined to be not irritating to skin in this assay.