3-phenylbutyraldehyde

Eye irritation

Administrative data

Endpoint:

eye 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:

not specified

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, 3-phenyl butanal
- Physical state: clear liquid
- Reference: 837-109-1

Test animals / tissue source

Species:

rabbit

Strain:

other: albino rabbit

Details on test animals or tissues and environmental conditions:

no data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Not applicable. The test material was not rinsed away after application in the eye.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

The test material was administered as 0.1 mL by volume into the eye of an albino rabbit without rinsing followed by gross observations daily under white light and under longwave ultra violet light subsequent to fluorescein staining. Corneal opacity was observed for 14 days.

Results and discussion

In vivo

Results

Irritation parameter:

other: Cornea, Iris, Fluorescein, Redness, Chemosis, Discharge

Basis:

mean

Time point:

other: 4 days

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: details are reported below

Irritant / corrosive response data:

The tested material was not an eye irritant when tested in rabbits by the method of Draize, as stated in the report. Transient damage to the corneal epithelium however, was observed in 3/6 rabbits as judged by fluorescein staining.
The tested material is considered to be slightly irritating, however it is not classified for this endpoint under CLP.

Any other information on results incl. tables

 

Rabbit#		Reading at Day
		0	1	2	3	4	7	14
1	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	N	N	N	N
	Redness	0	1	1	0	0
	Chemosis	0	1	0	0	0
	Discharge	0	1	0	0	0
2	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	+	+	N	N
	Redness	0	0	1	0	0
	Chemosis	0	1	1	0	0
	Discharge	0	1	1	1	0
3	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	N	N	N	N
	Redness	0	0	0	0	0
	Chemosis	0	0	0	0	0
	Discharge	0	0	0	0	0
4	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	+	N	N	N
	Redness	0	0	0	0	0
	Chemosis	0	1	0	0	0
	Discharge	0	1	1	1	0
5	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	N	N	N	N
	Redness	0	0	0	0	0
	Chemosis	0	1	1	0	0
	Discharge	0	1	1	1	0
6	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Fluorescein	N	+	N	N	N
	Redness	0	0	0	0	0
	Chemosis	0	1	0	0	0
	Discharge	0	1	0	0	0

 

Cornea & Iris - score of 1 or above is positive

Redness & Chemosis - score of 2 or above is positive

N = Negative

+ = Positive Fluorescein staining

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:

There were no positive scores indicating irritation to the eye. Slight redness, chemosis, and discharge were observed in some animals on some days of the study, but all animals were normal on Day 4. Overall, the data indicate that the substance is not irritating to the eye.

Executive summary:

An eye irritation study in rabbits was conducted to evaluate the potential of the substance to cause irritation to the eye. Following instillation of 0.1 mL of the undiluted substance into the eye, the only effects observed were slight redness, chemosis, and discharge in a few animals on some days of the study, with all animals showing scores of "0" by Day 4. There were no positive scores for these parameters, nor for readings of the cornea or iris. Fluorescein staining indicated transient damage to the corneal epithelium. Based on these results, the substance is considered not to be an irritant to the eye.