3-phenylbutyraldehyde

Endpoint summary

Description of key information

Skin irritation (rabbit): non irritating
Eye irritation (rabbit): non irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

Species:

rabbit

Strain:

other: Albino rabbits

Details on test animals or test system and environmental conditions:

no data available

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

Species:

rabbit

Strain:

other: albino rabbit

Details on test animals or tissues and environmental conditions:

no data available

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.

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.

 

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin irritation potential of the substance was evaluated in albino rabbits in a pre-GLP study (Gibraltar Laboratories, 1981a, dated November 20, 1981). Based on an overall primary irritation score of 1.8 in intact and/or abraded skin, it was concluded that the test material is not an irritant to skin.

The eye irritation potential of the substance was evaluated in albino rabbits in a pre-GLP study (Gibraltar Laboratories, 1981b, dated November 16, 1981). Although slight redness, chemosis, and discharge were observed in some animals of some days, it was concluded that the test material is not an irritant to the eye.

Justification for selection of skin irritation / corrosion endpoint:
Klimisch 2 study similar to guideline study

Justification for selection of eye irritation endpoint:
Klimisch 2 study similar to guideline study

Justification for classification or non-classification

Skin corrosion / irritation: the substance is non-corrosive and non-irritating in an in vivo skin irritation study. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.

Serious Eye Damage / Eye Irritation: the substance is non-corrosive and non-irritating in an in vivo eye irritation study. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.3.