1-dodecylpyridinium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Contact dermatitis to lauryl pyridinium chloride and benzoxonium chloride

Author:

DERK P. BRUYNZEEL, ANTON C. DE GROOT AND J. WILLEM WEYLAND

Year:

1987

Bibliographic source:

Contact Dermatitis 1987• 17: 41-60

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch tests with the European standard series (ICDRG)

Principles of method if other than guideline:

A patch was conducted on a 28-year-old male for test chemical according to the European standard series (ICDRG) after he had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-dodecylpyridinium chloride

EC Number:

203-232-2

EC Name:

1-dodecylpyridinium chloride

Cas Number:

104-74-5

Molecular formula:

C17H30N.Cl

IUPAC Name:

1-dodecylpyridin-1-ium chloride

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 1-Dodecylpyridinium chloride
- Molecular formula: C17H30N.Cl
- Molecular weight: 283.884 g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: [n+]1(ccccc1)CCCCCCCCCCCC.[ClH-]
- InChI: 1S/C17H30N.ClH/c1-2-3-4-5-6-7-8-9-10-12-15-18-16-13-11-14-17-18;/h11,13-14,16-17H,2-10,12,15H2,1H3;1H/q+1;/p-1

Test animals

Species:

other: human

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

- Age at study initiation: 28-year-old

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: Aqueous solution

Controls:

yes

Amount / concentration applied:

0.1%

Duration of treatment / exposure:

72 hr

Observation period:

48 and 72 hr

Number of animals:

1 (male)

Details on study design:

No data available

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48/ 72 hr

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Of 23 controls tested with 0.1% aq. test chemical , 16 were negative, 6 had a ? +, and 1 a+ reaction.

Any other information on results incl. tables

Skin irritation scores

Time (hours)	Rating
48	+
72	++

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

A positive reaction was observed to 0.1% aq. test chemical (48 h+, 72 h + +). Therefore, the test chemical was considered to be irritating to the human skin.

Executive summary:

A case study of 28-year old male has been summarized to for test chemical. In this study, a patch test was conducted on a 28-year-old male according to the European standard series (ICDRG) after he had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm at concentration of 0.1% aq for 48 and 72-hrs.

Of 23 controls tested with 0.1% aq. test chemical , 16 were negative, 6 had a ? +, and 1 a+ reaction.

A positive reaction was observed to 0.1% aq. test chemical (48 h+, 72 h + +). Therefore, the test chemical was considered to be irritating to the human skin.