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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

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

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

soya oil

Details on dermal exposure:

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 rmoeved 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.

Duration of exposure:

2 weeks

Doses:

0.0, 1.4, 2.8 and 5.6 ml/kg bw.

No. of animals per sex per dose:

4 per dose per sex.

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2.8 - <= 5.6 mL/kg bw

Based on:

test mat.

Mortality:

Yes

Clinical signs:

other: Erythema and edema.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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. Dupical was also concluded to be a severe primary skin irritant.

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.