4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde

EC Number:

250-078-7

EC Name:

4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde

Cas Number:

30168-23-1

Molecular formula:

C14H20O

IUPAC Name:

4-[(8Z)-tricyclo[5.2.1.0^{2,6}]decan-8-ylidene]butanal

Test material form:

liquid

Specific details on test material used for the study:

Dupical.
Stored in the dark at room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Eight male and eight female rabbits into 4 groups.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Abraded and intact skin

Vehicle:

other: Soya bean oil

Amount / concentration applied:

9 mL/kg bodyweight by appropriate dilution in soya bean oil.

Duration of treatment / exposure:

24 hour exposure.

Observation period:

Two weeks.

Number of animals:

16 rabbits (8 males and 8 females)

Details on study design:

Rabbits were shaved (approx: 10% of the trunk).
The test substance was placed onto shaved skin at dose levels of 0.0, 1.4, 2.8 and 5.6 ml/kg bw.
Half the animals received dose on intact skin and half on abraided skin.
The treated area was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.
After 24 hours, the test substance was romoved by washing with water.
Rabbits were observed for up to 2 weeks.
After 2 weeks blood composition and macroscopic appearance of heart, liver, kidneys, spleen and stomach were examined histologically.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24hr and 72hr mean

Score:

2.75

Max. score:

4

Reversibility:

other: Not assessed

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24hr and 72hr mean

Score:

1.6

Max. score:

4

Reversibility:

other: Not assessed

Remarks on result:

probability of moderate irritation

Results 3

Irritation parameter:

erythema score

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

48h not measured

Results 4

Irritation parameter:

edema score

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

48h not measured

Irritant / corrosive response data:

The skin reactions observed after 24 hours consisted of well-defined to moderate erythema, very slight to distinct ischemia and very slight or slight edema.
The skin reactions observed after 72 hours consisted of slight to moderate erythema, slight ischemia, slight or distinct scaliness and very slight or slight edema.

There were no distinct differences between skin reactions of the intact skin and those of the abraded skin.

Other effects:

Gross examination at autopsy showed abnormalities in the mid and high dose groups.
Mid dose one female had haemorrhages in the pancreas and a pale heart.
In the high dose group one male and one female had pale kidneys. This female also showed petachiae in the stomach.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

From the present results it can be concluded that Dupical is a severe primary skin irritant and that it is practically non-toxic when it is applied dermally in one single dose.

Executive summary:

The product Dupical was examined for primary skin irritating properties and acute dermal toxicity in experiments with albino rabbits.

Dupical was found to be a severe primary skin irritant.

The dermal LD50 of Dupical was found to be between 2.8 and 5.6 ml/kg body weight, suggesting it to be practically non-toxic in the case of one single dermal application.

Dermal application of Dupical at dose leels of 0.0 (control), 1.4, 2.8 and 5.6 ml/kg body weight caused moderate skin reactions at 1.4 ml/kg and moderate to severe skin reactions at 2.8 and 5.6 ml/kg, apathy at 2.8 and 5.6 ml/kg and paresis and/or paralysis at 5.6 ml/kg. Mortality amounted to 25% at 2.8 ml/kg and to 75% at 5.6 ml/kg.

The results on growth rate, food and water intake and haematology did not show toxicologically significant differences between test groups and controls.

Microscopic examination conducted terminally revealed treatment-related changes in the skin only.

It was concluded that Dupical is a severe primary skin irritant and that it is practically non-toxic when it is applied dermally in one single dose.