Lecithins, acetylated

Skin irritation / corrosion

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

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:

GHS criteria not met

Remarks:

not classified as an irritant

Conclusions:

There was no dermal irritation observed at any treated dose site during the study.

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. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.