Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 18 to 21 April 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study performed according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cepionate
- Substance type: pure active substance
- Physical state: colorless liquid
- Analytical purity: ca. 100%
- Isomers composition: ca. 30 % cis- and 70%- trans- isomers
- Lot/batch No.: 72019
- Stability under test conditions: stable
- Storage condition of test material: in a cool and dark place

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Conelli S.n.c., Via Milano 61, 28041 ARONA (Novara) - ITALY
- Age at study initiation: ca. 4 months
- Weight at study initiation: 2-3 kg
- Housing: metal cages measuring 62x47.5x38h cm with stainless steel feeders.
- Diet (e.g. ad libitum): ad libitum (produced by Charles River), periodically analyzed
- Water (e.g. ad libitum): ad libitum, periodically analyzed
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 2
- Humidity (%): 50 % ± 15
- Air changes (per hr): ca. 15 per hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (Blenderm3M Italia)

SCORING SYSTEM:

- Erythema and Escar formation (maximum score possible: 4):
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) to slight eschar formation (injuries in depth)

- Edema formation (maximum score possible: 4):
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond area ofexposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
other: No erythema was observed at any time
Irritation parameter:
edema score
Basis:
animal: # 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
other: No edema were observed at any time
Irritant / corrosive response data:
See Table 1 in "Any other information on results incl. tables"
Other effects:
None (no animal died during the study, no clinical signs or behavioral alterations were observed during the study in any rabbits).

Any other information on results incl. tables

Table 1: Dermal reactions observed

 

Time of observation

Animal n°

1

2

3

Erythema and Eschar

3 min

60 min

24 hours

48 hours

72 hours

0

0

0

0

0

-

0

0

0

0

-

0

0

0

0

Edema

3 min

60 min

24 hours

48 hours

72 hours

0

0

0

0

0

-

0

0

0

0

-

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Introduction.The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin following the application of the test article CEPIONATE (High ratio of Methylepi-dihydrojasmonate). The test method was in accordance with European Economic Community Guidelines - Annex to Commission Directive 92/69/EEC of July 31, 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances (B.4) and with Organization for Economic Cooperation and Development Guidelines (section 4, subpart 404, Paris 1981 and subsequent revisions).

 

Methods and Results. 0.5 ml of pure test article was applied to abraded skin of New Zealand White rabbits in occlusive conditions. Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. Since no serious gross skin reactions were noted, the test article was applied for an exposure period of 1 hour on the second site. Since no serious gross reactions were observed after the one-hour exposure period, the test article was applied for an exposure period of 4 hours on the third skin site. The test was completed using two additional animals with a 4 hour exposure period and a 72 hours observation period. None of the treated animals showed clinical signs or behavioral alterations. At the application sites, no signs of dermal irritancy were noted in any animal.

 

Conclusion.The test article when administered to rabbits by dermal route, under the experimental conditions adopted, has to be considered as non irritant for the skin.