Octanal, 2-(phenylmethylene)-, (2E)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 7 and 17 December 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to Annex VI directive 92/69/EEC Part B Method B.4 and under GLP Guidelines.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Hexyl Cinnamic Aldehyde
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 to 14 weeks old
- Weight at study initiation: 2.8 to 3.2 Kg
- Housing: housed individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit Diet provided ad libitum
- Water (e.g. ad libitum): provided ad libitum
- Acclimation period: no information


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ºC
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

11 days

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 100 mm X 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30 ºC to 40 ºC)
- Time after start of exposure: 4 hours. The treated area was blotted dry with absorbent paper


SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythema: 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema to slight eschar formation: 4

Oedema formation
No oedema: 0
Very slight oedema: 1
Slight oedema: 2
Moderate oedema: 3
Severe oedema: 4

Any other lesion not covered by this scoring system, was described.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: overall 24-48-72h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 11 days

Irritant / corrosive response data:

See Table 7.3.1/1

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Rabbit number and sex	E = Erythema O = Oedema	Day
		1	2	3	4	5	6	7	8	9	10	11
2791 male	E	2	2	2	2	a3	a3	a2	a1	a1	a1	0
	O	1	1	2	2	2	2	2	1	1	1	0
2792 male	E	2	2	2	2	a2	a2	a1	a1	a1	a1	0
	O	1	2	2	1	1	1	1	1	1	1	0
2793 male	E	2	2	2	2	2	a2	a0	a0	a0	a0	0
	O	1	2	2	2	1	1	1	1	1	1	0
a Desquamation of the stratum corneum

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information R38 Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions HCA is classified as irritating to skin (Xi; R38) according to the Directive 67/548/EEC but is not classified under the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In a dermal irritation study performed according to the EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) and in compliance with GLP, 3 male New Zealand White rabbits, were exposed to 0.5 mL of undiluted Hexyl cinnamic aldehyde (HCA). Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 11 days. 

The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 2/2/2 for erythema and 1.33/1.67/1.67 for edema. All the reactions were fully reversible within 11 days.

 

Under the test conditions HCA is classified as irritating to skin (Xi; R38) according to the Directive 67/548/EEC but is not classified under the Regulation (EC) No. 1272/2008 (CLP).

 

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.