7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

Rabbit study, enabling assessment of skin irritation and corrosion

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2nd 1992 - August 24th 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Proprietary guideline study, compliant wih the relevant guidelines.

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:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Number of animals used was in excess of guideline minimum

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

EC Number:

219-207-4

EC Name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Cas Number:

2386-87-0

Molecular formula:

C14H20O4

IUPAC Name:

7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Specific details on test material used for the study:

- Name of test material (as cited in study report): Cyracure UVR-6110
- Substance type: Not documented
- Physical state: Colourless, transparent, slightly viscous liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: 100% 3,4-epoxy cyclohexyl methyl-3,4 epoxy cyclohexyl
carboxylate
- Purity test date: Not documented
- Lot/batch No.: 55-61
- Stability under test conditions: Not documented
- Storage condition of test material: Stored at room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc. (Denver, PA).
- Age at study initiation: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg (males) and 2.6 to 3.5 kg (females)
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in.).
- Diet (e.g. ad libitum): AGWAY PROLAB Animal Diet High Fibre Rabbit was available ad libitum except during the actual dosing period.
- Water (e.g. ad libitum): Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 - 21.6°C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: 2 June 1992 To: 16 June 1992

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hour exposure period.

Observation period:

14 days
(Animals were observed at 1, 24, 48 and 72 hours and 7 and 14 days)

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: Not documented - test site was circa 2.5 x 2.5 cm
- Type of wrap if used: Polyethylene sheeting was placed loosely over the gauze patch on which the test substance was applied.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): As much excess test substance was removed as possible
- Time after start of exposure: Following the 4 hour exposure period.

SCORING SYSTEM: Draize scoring method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

ca. 1.35

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: No irreversible tissue destruction noted.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hours

Score:

0.8

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 2 days

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Application of 0.5 ml of CYRACURE UVR-6110 to covered rabbit skin for a 4-hour contact period produced minor erythema on 6 of 6 rabbits. Minor transient oedema was produced on 3 animals. There was no oedema present on any animal by 2 days. Erythema subsided on all rabbits within 14 days.

Other effects:

There was no irreversible tissue destruction noted.

Any other information on results incl. tables

Using the EU criteria for assessing skin irritation the mean score for 24, 48 and 72 hours for erythema was 0.833 and for oedema was 0.17. Recovery was complete within 14 days for erythema and within 2 days for oedema.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the test substance, CYRACURE UVR-6110 was not considered to be a skin irritant. As a result of this, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC as the criteria were not fulfiled for erythema and oedema.

Executive summary:

In a study conducted by Myers et al, (1992), the test substance, CYRACURE UVR-6110 was investigated for its potential to act as a skin irritant. The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5ml of the test substance was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test substance was 4 hours after which, as much excess test substance as possible was removed.

The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test substance was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.