1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

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:

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:

Skin irritation potential of test chemical

Author:

E. Berardesca et. al.

Year:

1990

Bibliographic source:

Contact Dermatitis, 1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: plastic occlusion stress test (POST) technique.

Principles of method if other than guideline:

Irritant effects and disturbance of water-holding capacity induced by test chemical were investigated using the plastic occlusion stress test (POST) technique.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

EC Number:

263-058-8

EC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Cas Number:

61789-40-0

Molecular formula:

C19H38N2O3

IUPAC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Details on test material:

- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Molecular formula : C19H38N2O3
- Molecular weight : 342.52 g/mol
- Smiles notation : CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}
- Substance type : Organic

Test animals

Species:

other: humans

Strain:

not specified

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Department of Dermatology, University of Pavia, Italy
- Age: 32+/- 4 years

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.03 ml/sqcm of 7% test chemical in distilled water

Duration of treatment / exposure:

Once daily for 3 days

Observation period:

24 hours after removal of POST

Number of animals:

8 healthy white men

Details on study design:

TEST SITE
- Area of exposure: volar forearm
- % coverage: 16 sq cm
- Type of wrap if used: no data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: skin surface water loss (SSWL) and transepidermal water loss (TEWL) were recorded using an evaporimeter. SSWL and TEWL readings were corrected for a skin temperature of 30 deg C.SSWL decay constants were calculated for each subject according to method described by Wagner

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: SSWL

Basis:

mean

Time point:

other: 1 MINUTE

Score:

44.7

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

other: SSWL

Basis:

mean

Time point:

other: 25 MINUTES

Score:

12.1

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

At the 1st minute, statistically significant differences were detected between control and test chemical

Any other information on results incl. tables

SSWL values(g/sqmh) corrected for skin temperature at the 1^stand 25^thminute(+/- standard error) and SSWL decay constants

Test chemical	1^stminute	25^thminute	Decay constant
Cocamidopropyl betaine	44.7±7.8*	12.0±2.0*	-0.046
Control	40.5±3.9*	8.7±1.*	-0.056

The differences between the surfactants are statistically significant (Friedman’s test p<0.01)

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

At the 1st minute, statistically significant differences were detected between control and test chemical. The SSWL values (g/sqmh) at the 1st and 25th minute for the test chemical were 44.7 and 12.1 respectively. Based on these values, test chemical can be considered to be irritating to human skin.

Executive summary:

Irritant effects and disturbance of water‐holding capacity induced by test chemical were investigated using the plastic occlusion stress test (POST) technique. Doses for the test were determined on the basis of the irritant potential of the test chemical and its use in marketed products. 7% test chemical in distilled water was applied to the open marked sites once daily for 3 days on the volar forearms of the 8 White male volunteers. The sites were allowed to dry without washing. On the 4^thday, a 1inch diameter occlusive plastic device was applied for 24 hours on both the treated and an adjacent control site, in order to produce hydration for theplastic occlusion stress test (POST). After removal of the devices, excess water was wiped with tissue papers and the SSWL was recorded continuously with an Evaporimeter. Skin temperature was recorded by a digital thermometer. Statistical analysis was performed using the non parametric Freidman test and Fischer PLSD test. At the 1^stminute, statistically significant differences were detected between control and test chemical. The SSWL values (g/sqmh) at the 1^stand 25^thminute for the test chemical were 44.7 and 12.1 respectively. Based on these values, test chemical can be considered to be irritating to human skin.