3-(4-tert-butylphenyl)propionaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: FDA Standards

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Bourgeonal

IUPAC Name:

Bourgeonal

Constituent 2

Reference substance name:

3-(4-tert-butylphenyl)propionaldehyde

EC Number:

242-016-2

EC Name:

3-(4-tert-butylphenyl)propionaldehyde

Cas Number:

18127-01-0

Molecular formula:

C13H18O

IUPAC Name:

3-(4-tert-butylphenyl)propanal

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Bourgeonal
- Substance type: clear colourless liquid
- Physical state: Liquid
- Lot/batch No.: 148983

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.

- Age at study initiation:
Adult

- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.5 - 3.0 kg

- Housing:
Not specified in the report

- Diet (e.g. ad libitum):
Not specified in the report

- Water (e.g. ad libitum):
Not specified in the report

- Acclimation period:
Not specified in the report

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not specified in the report

- Humidity (%):
Not specified in the report

- Air changes (per hr):
Not specified in the report

- Photoperiod (hrs dark / hrs light):
Not specified in the report

Test system

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted bourgeonal

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
0.2 ml

- Concentration (if solution):
Not applicable.

VEHICLE
- Amount(s) applied (volume or weight with unit):
Not applicable

- Concentration (if solution):
Not applicable.

- Lot/batch no. (if required):
Notapplicable

Duration of treatment / exposure:

72 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure:
On the day of the test a suitable test site was selected on the back of each rabbit.

- % coverage:
Not given in study report.

- Type of wrap if used:
Test material was brought into contact with separated skin areas left of the midline of the back.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not reported

- Time after start of exposure:
72 hours.


SCORING SYSTEM:
The resulting skin reactions were evaluated by the method of Draize (J. Pharm. Exptl. Therap. 82 (1944) 377-390) 24, 48, 72 and 96 hours after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 8803

Time point:

24/48/72 h

Score:

2

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Results 2

Irritation parameter:

erythema score

Basis:

animal: 8804

Time point:

24/48/72 h

Score:

3

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Results 3

Irritation parameter:

erythema score

Basis:

animal: 8805

Time point:

24/48/72 h

Score:

3

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Results 4

Irritation parameter:

edema score

Basis:

animal: 8806

Time point:

24/48/72 h

Score:

2

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Results 5

Irritation parameter:

edema score

Basis:

animal: 8807

Time point:

24/48/72 h

Score:

3

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Results 6

Irritation parameter:

edema score

Basis:

animal: 8808

Time point:

24/48/72 h

Score:

3

Max. score:

8

Reversibility:

no data

Remarks on result:

other: time point 48 hours was not examined

Irritant / corrosive response data:

Individual and average skin irritation scores are given in table 1. Bourgeonal caused severe skin irritation. Its dermal effects generally consisted of focal haemorrhages, slight to distinct ischemia and incrustation, and very slight edema.

Other effects:

None

Any other information on results incl. tables

TABLE 1 - INDIVIDUAL AND AVERAGE SKIN IRRITATION SCORES OF BOURGEONAL

Rabbit Number	Intact Skin		Rabbit Number	Abraded Skin
	24 hours	72 hours		24 hours	72 hours
	A                         B			A                        B
8803	4          -            1	2	8797	4          -            1	2
8804	4          -            1	3	8798	4          -            1	2
8805	4          -            1	3	8799	4          -            1	3
8806	4          -            1	2	8800	4          -            1	3
8807	4          -            1	3	8801	4          -            1	2
8808	4          -            1	3	8802	4          -            1	2
Average	5.0	2.7	Average	5.0	2.3

A = erythema

B = edema

The resulting skin reactions were evaluated by the method of Draize (J. Pharm. Exptl. Therap. 82 (1944) 377-390) 24, 48, 72 and 96 hours after application.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the present results it can be concluded that undiluted Bourgeonal is a severe primary skin irritant.

Executive summary:

The product bourgeonal was examined in primary skin irritation using New Zealand White albino rabbits as the experimental animals.

Pure and undiluted bourgeonal caused severe skin irritation.