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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
other: SSWL
Basis:
mean
Time point:
other: 1 MINUTE
Score:
44.7
Reversibility:
not specified
Remarks on result:
positive indication of irritation
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 1stand 25thminute(+/- standard error) and SSWL decay constants

Test chemical

1stminute

25thminute

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 4thday, 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 1stminute, statistically significant differences were detected between control and test chemical. The SSWL values (g/sqmh) at the 1stand 25thminute 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.