Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to the Draize procedure. Worst-case conditions were used (24 h occlusive exposure) and observation were performed at 24 and 72h only. However only slight effects were observed after 24 hours, and were completely reversible within 72 hours. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Study was performed according to Draize procedure (Draize, 1944).

GLP compliance:

no

Remarks:

(pre-GLP)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE

Molecular formula:

C12H18O

IUPAC Name:

Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): 0878/2

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

None

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: After test material application, entire trunk of each animal was covered with an impermeable occlusive wrapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Test material was removed 24 h following application.

SCORING SYSTEM: According to Draize method (1944).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(6 animals)

Time point:

other: Mean 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(6 animals)

Time point:

other: Mean 24 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Irritant / corrosive response data:

- Very slight erythema observed in all animals which was reversible within 72 h.

Other effects:

No data

Any other information on results incl. tables

Table 7.3.1/1: Mean skin irritant/corrosive response data for 6 animals at each observation time

Score at time point / Reversibility	Intact skin		Abraded skin
	Erythema Max. score 4	Oedema Max. score 4	Erythema Max. score 4	Oedema Max. score 4
24 h	1/1/1/1/1/1	0/0/0/0/0/0	1/1/1/1/1/1	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24 and 72 h for 6 animals	0.5	0	0.5	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test material induced very slight erythema which was reversible within 72 h. Therefore the test material is not classified as irritant to the skin.

Executive summary:

In a dermal irritation study performed following the Draize procedure, 0.5 mL (0.5 g) of undiluted test material was dermally applied on the clipped areas of intact and abraded skin of 6 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.

The test material induced very slight erythema which was reversible within 72 h. The mean scores calculated for all animals within 2 scoring times (24 and 72 hours) were 0.5 for erythema and 0.0 for oedema.

Therefore the test material is not classified as irritant to the skin according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

Although some details on experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for skin irritation endpoint.