3-phenylbutyraldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study performed accordingly to accepted guidelines. Test report is not fully documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: see below

Deviations:

yes

Remarks:

Observation at 48-hr was not recorded

Principles of method if other than guideline:

Guidelines (as stated on the report):
(1) Draize et al in “Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics”, Assoc. of Food and Drug Officials of the U.S., (1965) P-C. Box 1494, Topeka, Kansas;
(2) Marzulli, F.N. and Ruggles, D.l., Jour AOAC 56 (1973);
(3) Federal Hazardous Substances Act, CFR Title 16, Chap. 11, Parts 1500.3, 1500.40, 1500.41, 1500.42.

GLP compliance:

no

Remarks:

pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

3-phenylbutyraldehyde

EC Number:

240-362-9

EC Name:

3-phenylbutyraldehyde

Cas Number:

16251-77-7

Molecular formula:

C10H12O

IUPAC Name:

3-phenylbutanal

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Trifernal, CF-3PB
- Physical state: clear liquid
- Reference: 837-109-2

Test animals

Species:

rabbit

Strain:

other: Albino rabbits

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

No data available. Duration of treatment / exposure is expected to be 4 hrs as described in the guidelines.

Observation period:

72 hours

Number of animals:

6 rabbits

Details on study design:

0.5 ml under gauze dressing to the clipped intact ("int.") and abraded ("abr.") skin of adult albino rabbits with observations for erythema and edema at 24 and 72 hours.

Results and discussion

In vivo

Results

Irritation parameter:

other: primary irritation score

Basis:

mean

Time point:

other: 24 - 72 hrs

Score:

1.8

Max. score:

2.5

Reversibility:

no data

Remarks on result:

other: details are reported below

Irritant / corrosive response data:

The tested material produced a primary skin irritation score of 1.8, including consideration of data for intact and abraded skin. The tested material is slightly irritating, however it is not classified for this endpoint, as stated in the report, according to guidelines of the Consumer Product Safety Commission..
As described in the report, a score of "5" or more is considered indicative of a primary irritant.

Any other information on results incl. tables

Results for erythema and eschar scoring, and edema scoring, are provided below.

Animal#	Erythema & Eschar				Edema				Individual primary irritation score
	24		72		24		72
	Int.	Abr.	Int.	Abr.	Int.	Abr.	Int.	Abr.
1	1	1	2	2	1	1	0	1	2.25
2	2	2	2	2	0	0	0	0	2.0
3	1	1	1	1	0	0	0	0	1.0
4	1	1	1	1	0	0	2	2	2.0
5	2	2	2	2	0	0	1	1	2.5
6	1	1	1	1	0	0	0	0	1.0

Int. = intact skin; Abr = abraded skin.

Individual primary irritation scores were a sum of all scores for an animal divided by 4. Both intact and abraded skin scores were included in the calculation of the overall primary irritation score of 1.8 considering the average value of the individual primary irritation scores.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Conclusions:

Based on the overall irritation score for both intact and abraded skin being 1.8, the substance would not be considered a skin irritant under CLP.

Executive summary:

A skin irritation study in rabbits was conducted to determine the potential of the substance to act as a skin irritant. The substance was applied undiluted under gauze dressing to clipped intact as well as abraded skin, and skin responses were evaluated at 24 and 72 hours. While the scoring system was not provided in the available report, and both intact and abraded testing was conducted, it was noted that the maximum score for any animal at any time point was 2 (a score of 5 would have been considered an indication of a primary irritant). Additionally, the intact and abraded sites showed similar scores. The overall primary irritation score was 1.8. As such, the substance is not considered a skin irritant.