Bis[(3,4-epoxycyclohexyl)methyl] adipate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 June 1992 to 24 August 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

other: read-across target

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

other information

Justification for type of information:

Read across to substance with the same functional groups.

Reason / purpose for cross-reference:

read-across source

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

Test material form:

liquid

Details on test material:

- Appearance: Colourless, transparent, slightly viscous liquid
- 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
- 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: ad libitum except during the actual dosing period.
- Water: 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: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: 02 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 material was applied.
- Following application of the test material, the animals were placed in a restraining device for the 4 hour contact period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): As much excess test material 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:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

Application of 0.5 mL of the test material 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:

GHS criteria not met

Conclusions:

Based on the results of this study, the test material was not considered to be a skin irritant. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008 as the criteria were not fulfilled for erythema and oedema.

Executive summary:

In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions.

The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material 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 material was 4 hours after which, as much excess test material 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 material 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.