Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Lecithins, acetylated
EC Number:
293-316-5
EC Name:
Lecithins, acetylated
Cas Number:
91053-50-8
Molecular formula:
Not applicable- complex UVCB substance
IUPAC Name:
91053-50-8
Details on test material:
Purity: Unknown variable composition biological substance (UVCBS)
Composition of test material, percentage of components: Unknown variable composition biological substance (UVCBS)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2082-2350 grams
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 ºC
- Humidity (%): 65-70 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
30-60 min and at 24, 48, and 72 hours
Number of animals:
3 animals: 1 male , 2 female
Details on study design:
TEST SITE
- Area of exposure: 6-cm2 dose site on dorsal area and the trunk
- Type of wrap if used: A 1-inch x 1-inch, 4-ply gauze pad covered the test area. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-, 48-, and 72-hour dermal responses
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-, 48-, and 72-hour dermal responses
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no dermal irritation observed at any treated dose site during the study.

See Table 1 for complete individual rabbit scores

Any other information on results incl. tables

Table 1: Results are listed as ERYTHEMA/EDEMA

Animal No.

Sex

Time After Patch Removal

30-60 mins

24 hrs

48 hrs

72 hrs

1

M

0/0

0/0

0/0

0/0

2

F

0/0

0/0

0/0

0/0

3

F

0/0

0/0

0/0

0/0

Applicant's summary and conclusion

Interpretation of results:
other: not classified as an irritant
Remarks:
Criteria used for interpretation of results: other: Directive 67/548/EEC and Globally Harmonized System (GHS)
Conclusions:
There was no dermal irritation observed at any treated dose site during the study.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application. The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4-hours. Five-tenths of a millilitre of the test substance was applied to the skin of one healthy rabbit for 4-hours. The dose site was evaluated for dermal irritation by the method of Draize immediately following patch removal, and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since no dermal irritation was noted in this animal, the test was completed on two additional animals, as described above. There was no dermal irritation observed at any treated dose site during the study. In accordance with the provisions of Directive 67/548/EEC, classification by the dermal route is not required based on the results of this study. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.