3,7,7-trimethylbicyclo[4.1.0]heptane-2-carbaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 august to 04 september 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study conducted in compliance with OECD 404 without any deviation and not under GLP

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:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7,7-trimethylbicyclo[4.1.0]heptane-2-carbaldehyde

EC Number:

272-323-7

EC Name:

3,7,7-trimethylbicyclo[4.1.0]heptane-2-carbaldehyde

Cas Number:

68804-33-1

Molecular formula:

C11H18O

IUPAC Name:

3,7,7-trimethylbicyclo[4.1.0]heptane-2-carbaldehyde

Test material form:

liquid

Details on test material:

No confidential details

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: COB.LABO.LAP (22120 YFFINIAC, France)
- Weight at study initiation: 1.9 kg
- Number and sex : 2 females and 1 male
- Housing: 1 animal per cage

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

Obervation at 1, 24, 48 and 72h after the removal of the patch.

Number of animals:

2 females and 1 male

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1h

Score:

1

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

2

Reversibility:

not specified

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

7 d

Score:

0

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1h

Score:

0

Reversibility:

not specified

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Results 9

Irritation parameter:

edema score

Basis:

animal #1

Time point:

7 d

Score:

0

Results 10

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1h

Score:

1

Reversibility:

not specified

Results 11

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

not specified

Results 12

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

7 d

Score:

0

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1h

Score:

0

Results 14

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

not specified

Results 15

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

0

Results 16

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Results 17

Irritation parameter:

edema score

Basis:

animal #2

Time point:

7 d

Score:

0

Results 18

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1h

Score:

1

Reversibility:

not specified

Results 19

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

not specified

Results 20

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48 h

Score:

2

Reversibility:

not specified

Results 21

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

0

Results 22

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1h

Score:

0

Results 23

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 24

Irritation parameter:

edema score

Basis:

animal #3

Time point:

7 d

Score:

0

Irritant / corrosive response data:

At 24h a slight erythema was observed for two rabbits and at 48h a slight erythema was observed for all rabbits.
A slight edema was observed for two rabbits 24h after treatment but effects were reversibles after 72h.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In accordance with Regulation EC No. 1272/2008, the test substance has to be classified as skin irritant.

Executive summary:

An in vivo skin irritation test on rabbit was conducted according to Guideline OECD 404 to predict the acute skin irritation potential of the test substance.

At 24h a slight erythema was observed for two rabbits and at 48h a slight erythema was observed for all rabbits.

A slight edema was observed for two rabbits 24h after treatment but effects were reversibles after 72h.

Therefore, in accordance with Regulation EC No. 1272/2008, the test substance has to be classified as skin irritant category 2.