Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed under GLP and follows a method similar to an OECD guideline; limited test material characterisation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Molecular formula:

C12H18O

IUPAC Name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: recognised animal supplier
- Age at study initiation: no data
- Weight at study initiation: 2 - 4 kg
- Housing: individually housed in wire mesh bottom cages.
- Diet (e.g. ad libitum): certified animal feed ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

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
- Concentration (if solution): undiluted

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: each test site was occluded with a one-inch square gauze patch. The trunk of each animal was then wrapped with an occlusive binder -this consisted of a layer of plastic wrap, a protective cloth and a stockinette sleeve all secured in place with masking tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible.
- Time after start of exposure: 24h

SCORING SYSTEM: Draize scoring system.

Results and discussion

In vivo

Results

Irritation parameter:

other: mean primary irritation score

Basis:

mean

Time point:

other: 72

Score:

0.75

Max. score:

8

Reversibility:

fully reversible

Irritant / corrosive response data:

All animals developed very slight to moderate erythema at the 24h observation period. By the 72h observation period these effects had fully reversed.

Any other information on results incl. tables

Table 1. Primary score irritation scores

	Time	Skin	Rabbit
			1	2	3	4	5	6
Erythema and eschar formation	24	Intact	2	1	1	2	2	1
	72	Intact	0	0	0	0	0	0
	24	Abraded	2	1	1	2	2	1
	72	Abraded	0	0	0	0	0	0
Total (a)			4	2	2	4	4	2
Oedema formation	24	Intact	0	0	0	0	0	0
	72	Intact	0	0	0	0	0	0
	24	Abraded	0	0	0	0	0	0
	72	Abraded	0	0	0	0	0	0
Total (b)			0	0	0	0	0	0
Overall total (a + b)			4	2	2	4	4	2
Individual animal scores			1	0.5	0.5	1	1	0.5
Mean score			0.75

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the authors report that the test material is slightly irritating to the skin of New Zealand White rabbits. However according to the CLP classification system, the test material is not considered to be irritating to skin.

Executive summary:

The study was performed to assess the skin irritation potential of the test material in New Zealand White rabbits. The study was performed under GLP and followed a method similar to OECD guideline 404. A volume of 0.5 ml of undiluted test material was applied to each of 2 sites per rabbit. The test sites were separated by the spinal column. Prior to test article application, the test site on the right dorsal side was abraded with the tip of a 22 gauge hypodermic needle. The abrasions were 4 incisions made in cross hatch which penetrated the stratum corneum but did not disturb the derma and/or produce bleeding. Following application, each test site was occluded with a one-inch square gauze patch. The trunk of each animal was then wrapped with an occlusive dressing. At the 24h observation period, all animals developed very slight to moderate erythema; by the 72h observation period these effects had fully reversed. An overall mean primary irritation score was determined as 0.75. Under the conditions of this study, the authors report that the test material is slightly irritating to the skin of New Zealand White rabbits. However according to the CLP classification system, the test material is not considered to be irritating to skin.