Exo-1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1S,2S)-1-methyl-4-(propan-2-yl)-7-oxabicyclo[2.2.1]heptan-2-ol

Cas Number:

87172-89-2

IUPAC Name:

(1S,2S)-1-methyl-4-(propan-2-yl)-7-oxabicyclo[2.2.1]heptan-2-ol

Test material form:

solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test substance was stored in the dark at ambient temperature

FORM AS APPLIED IN THE TEST
Preparation of the test substance for formulation: The test substance as received was contained in a narrow necked vessel. Before being used for formulation purposes all of the test substance was melted in an oven at 70 °C, well mixed, and then sub-sampled into smaller vessels. One of these sub-samples was submitted to the Analytical Chemistry Division for analysis.
Formulation of the test substance: The test substance was supplied as a ground up solid for the skin irritancy test. Grinding was carried out using a pestle and mortar.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rabbits were obtained from Sittingbourne Research Centre Breeding unit.
- Age at study initiation: 4 - 9 months
- Weight at study initiation: Males: 3486 to 4124 g; Females: 4560 to 4868 g
- Housing: The animals were singly housed in hanging, stainless-steel cages with perforated dimple or all-mesh floors, all mesh tops and half-mesh fronts; each cage mesured 67 cm x 43 cm x 45 cm. The cages were mounted in three rows of two on a single-sided rack (total of six cages).
- Diet: Standard Rabbit Diet, S.Q.C., Special Diet Services Ltd., Essex; provided ad libitum by means of a top-loading food hopper
- Water: Water (filtered but untreated from public supply) was provided ad libitum by means of an automatic valve-regulated drinking line.
- Acclimation period: At least two weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 250 mg (this dose equating the largest dose that could practicably be used)

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

6 (3 animals per sex)

Details on study design:

TEST SITE
- Area of exposure: 2 cm x 2 cm
- Type of wrap if used: The test powder and surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes. After 4 hours the wrapping and patch were removed and the test site washed with water and gently dried.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS: 30 min, 24h, 48h, 72h and 7 days

SCORING SYSTEM: See table 1 for details.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4, 24, 48, 72 h and 7d

Score:

0

Max. score:

4

Remarks on result:

other: See table 2 for detailed information

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4, 24, 48, 72 h and 7d

Score:

0

Max. score:

4

Remarks on result:

other: See table 2 for detailed information

Any other information on results incl. tables

Table 2: Primary irritation of semi-occluded rabbit skin after a single application of the test item (4 hours exposure)

Animal No & sex	Response	4 hours	24 hours	48 hours	72 hours	7 days
937 M	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
934 M	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
935 M	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
917 F	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
920 F	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
915 F	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
Mean Erythema score		0	0	0	0	0
Mean Oedema score		0	0	0	0	0

Scale:

Erythema readings 0 = No erythema to 4 = Beet redness

Oedema readings 0 = No oedema to 4 = Severe oedema