Cyclopentaneacetic acid, 3-oxo-2-pentyl-, methyl ester, (1R,2S)-rel-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From 18 to 21 April 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

OECD Guideline study performed according to GLP. The study was fully reliable (Klimisch score = 1), however the reliability score was lowered to 2 which is the maximum score for read-across. The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 3-oxo-2-pentylcyclopentaneacetate

EC Number:

246-495-9

EC Name:

Methyl 3-oxo-2-pentylcyclopentaneacetate

Cas Number:

24851-98-7

IUPAC Name:

methyl (3-oxo-2-pentylcyclopentyl)acetate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Cepionate
- Substance type: pure active substance
- Physical state: colorless liquid
- 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 or test system 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)

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 1, #2 and #3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No erythema was observed at any time

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No oedema 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 behavioural 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
Oedema	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

Conclusions:

At the application sites, no signs of dermal irritancy were noted in any animal. The test material is not classified as irritant to the skin.

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 labelling 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 behavioural alterations. At the application sites, no signs of dermal irritancy were noted in any animal.

 

Conclusion. The test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).

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