Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment of Stearalkonium Chloride

Author:

Cosmetic Ingredient Review Expert Panel

Year:

1990

Bibliographic source:

International Journal of Toxicology, Vol 1, Issue 2, pp. 57 – 69, 1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize method

Principles of method if other than guideline:

To evaluate the primary dermal irritation potential according to Draize procedure

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldimethyl(octadecyl)ammonium chloride

EC Number:

204-527-9

EC Name:

Benzyldimethyl(octadecyl)ammonium chloride

Cas Number:

122-19-0

Molecular formula:

C27H50ClN

IUPAC Name:

N-benzyl-N,N-dimethyloctadecan-1-aminium chloride

Test material form:

solid

Details on test material:

Name of the test chemical:Stearalkonium Chloride
Molecular Formula: C27H50N.Cl
Molecular Weight:424.152 g/mol
Substance Type: Organic
Physical state: Solid

Specific details on test material used for the study:

Name of the test chemical:Stearalkonium Chloride
Molecular Formula: C27H50N.Cl
Molecular Weight:424.152 g/mol
Substance Type: Organic
Physical state: Solid

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 ml of 25%, 2.5%, and 1.25% solutions of the test chemical

Duration of treatment / exposure:

24 hours

Observation period:

24, 72 hours

Number of animals:

not mentioned

Details on study design:

Details on study design
TEST SITE
- Type of wrap if used: The treated areas were covered with gauze and wrapped to keep the test material in contact with the skin and to decrease the rate of vaporization. The wrapping and test material were removed 24 hours following application.

SCORING SYSTEM:
The wrapping and test material were removed 24 hours following application and the sites examined and scored separately for erythema and edema at 24 and 72 hours. Primary dermal irritation indices were calculated according to the Draize procedure for 25%, 2.5%, and 1.25% concentrations of the material. The mean scores for 24- and 72-hour readings were averaged to determine the irritation index.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

6

Remarks on result:

other: for 25% solution

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

2.4

Remarks on result:

other: for 1.25% solution

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

1

Remarks on result:

other: for 2.5% solution

Irritant / corrosive response data:

Primary Dermal Irritation Indices were as follows - 6.0 = 25% solution, 2.4 = 1.25% solution, 1.0 = 2.5% solution

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Primary dermal irritation indices were calculated according to the Draize procedure for 25%, 2.5%, and 1.25% concentrations of Stearalkonium Chloride. Primary irritation indices were calculated to be 6.0, 2.4, and 1.0 for the 25%, 1.25%, and 2.5% solutions, respectively.
Based on the primary irritation indices, Stearalkonium Chloride can be considered as mild irritant to skin.

Executive summary:

The primary dermal irritation potential ofStearalkonium Chloride was evaluated according to Draize method. Adult rabbits were used for the study. 0.5 ml of 25%, 2.5%, and 1.25% solutions of the test chemical was applied to clipped areas of intact and abraded rabbit skin. The treated areas were covered with gauze and wrapped to keep the test material in contact with the skin and to decrease the rate of vaporization. The wrapping and test material were removed 24 hours following application. The sites were examined and scored separately for erythema and edema at 24 and 72 hours. Primary dermal irritation indices were calculated according to the Draize procedure for 25%, 2.5%, and 1.25% concentrations of the material. The mean scores for 24- and 72-hour readings were averaged to determine the irritation index. Primary irritation indices were calculated to be 6.0, 2.4, and 1.0 for the 25%, 1.25%, and 2.5% solutions, respectively.

Based on the primary irritation indices, Stearalkonium Chloride can be considered as mild irritant to skin.