Methoxycarbonyloxycyclooct-4-ene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 30, 1985 - August 02, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

not in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.

Test material

Test material information

Constituent 1

Reference substance name:

Methoxycarbonyloxycyclooct-4-ene

EC Number:

401-620-8

EC Name:

Methoxycarbonyloxycyclooct-4-ene

Cas Number:

87731-18-8

Molecular formula:

C10H16O3

IUPAC Name:

(1R,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (1S,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (3Z)-cyclooct-3-en-1-yl methyl carbonate; (4Z)-cyclooct-4-en-1-yl methyl carbonate; bicyclo[3.2.1]octan-8-yl methyl carbonate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Essex, UK
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: no data available; only stated that animals were acclimated to lab environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
Hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm2 24 hours before application. The test substance was applied under a 2.5 cm2 gauze pad to one intact skin site on each animal. Each treatment site was occluded with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using ethyl alcohol to remove any residual test substance.

SCORING SYSTEM:
Dermal irritation is graded and recorded according to the system described in OECD 404. Any other lesion not covered by the scoring system, will be described. Skin was graded 30 minutes, 24, 48 and 72 hours after removal of the dressing.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Animal #1

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Animal #2 and #3

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Animal #1

Results 4

Irritation parameter:

edema score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Animal #2 and #3

Irritant / corrosive response data:

Very slight erythema, with or without very slight oedema was seen in two animals 24 and 48 hours after removal of the dressing.

Applicant's summary and conclusion

Interpretation of results:

other: Not an irritant in accordance with EU CLP (EC no. 1272/2008 and its amendments)

Conclusions:

The substance does not cause skin irritation in the in vivo acute dermal irritation test (OECD TG 404).

Executive summary:

The substance was tested in a skin irritation test in female rabbits (OECD TG 404). New Zealand White rabbits were exposed to 0.5 mL of the substance for 4 hours in a semiocclusive manner. Very slight erythema, with or without very slight oedema was seen in two animals 24 and 48 hours after removal of the dressing. The observations were fully reversible within 72 hours. Average erythema and edema scores (24/48/72 hr) in those two animals were 0, 0.67 and 0.67 and 0, 0.33 and 0.33, respectively. Based on these results, the substance does not cause skin irritation.