Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EEC guideline 84/449/EEC, 1984-09-19
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc diricinoleate
EC Number:
235-911-4
EC Name:
Zinc diricinoleate
Cas Number:
13040-19-2
Molecular formula:
C18H34O3.1/2Zn
IUPAC Name:
zinc bis(12-hydroxyoctadec-9-enoate)
Constituent 2
Reference substance name:
9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
IUPAC Name:
9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
Constituent 3
Reference substance name:
zinc ricinoleate
IUPAC Name:
zinc ricinoleate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Harald Schriever, Kaninchenfarm, D-2740 Bremervörde
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging
- Diet (e.g. ad libitum):Sniff, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2
- Humidity (%): 50 - 85
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left side shaved and abraded, right side shaved.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g; the test substance was applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The test substance was applied on the right (intact) and left (scarified) back (size of areas each about 2.5 x 2.5 cm). At once the treated test areas and the untreated control areas underneath the test areas were secured with "Kosmoplast" and gauze pads. After that the whole trunk was wrapped with "Elastoplast" (permeable to air). Besides the trunk was wrapped with "Stülpa". This skin occlusive dressing was left on the skin for 4 hours. After that time the bandage was removed and residues of the sample were removed with gentle lukewarm water.

Results and discussion

In vivo

Results
Irritation parameter:
other: Individual scoring according to Draize scheme
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
24
Irritant / corrosive response data:
No erythema and no edema was observed on intact and on scarified skin areas.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Grillocin PY 88 is not irritating to skin.
Executive summary:

The test substance is a white solid powder and was tested regarding its acute skin irritation potential in 6 rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). Dermal reactions at the treated skin sites (scarified and intact) were assessed 4 hours and 24, 48, and 72 hours after application of the test substance. Skin reactions have not been observed, numerical scores for erythema and edema were “0” for all observations. Grillocin PY 88 is valuated as not irritant to skin.