(R)-3,7-dimethyloct-6-enal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

The test substance (Citronellal; CAS 106-23-0) represents the racemate of the registered substance (R)-3,7-dimethyloct-6-enal (CAS 2385-77-5).

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize Test (Federal Register, No. 187, § 1500.41, p. 27029 from 27.09.73)

Principles of method if other than guideline:

0.5 mL of undiluted citronellal applied to intact and abraded skin for 24 hrs under occlusion, post-observation 8 d

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Citronellal

EC Number:

203-376-6

EC Name:

Citronellal

Cas Number:

106-23-0

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethyloct-6-enal

Details on test material:

- Name of test material (as cited in study report): Citronellal 3,7-Dimethyl-6-octenal

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Body weight (mean): m 2.75 kg, f 2.57 kg
- Diet: SSNIFF (Intermast) ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on a square of 2.5 x 2.5 cm
- Concentration: undiluted

Duration of treatment / exposure:

24 hours

Observation period:

8 d

Number of animals:

3 m, 3 f

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

SCORING SYSTEM:
Edema: 0=none, 1=questionable, 2=slight, 3=strong, 4=severe
Erythema: 0=none, 1=questionable, 2=slight, 3=strong, 4=severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1-6

Time point:

other: mean from 24, 48 and 72 h

Score:

2.21

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: after 8 days erythema score was 1 in 6/6 rabbits, all rabbits showed desquamation,

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1-6

Time point:

other: mean from 24, 48 and 72 h

Score:

2.05

Max. score:

4

Reversibility:

fully reversible within: 8 days

Any other information on results incl. tables

Table: Skin irritation scores after a 24-h application of citronellal

Readings	Animal	Exposure period: 24 h
		Erythema	Edema	Additional findings
				Erythema	Edema
24 h	1	2	2
	2	2	2	ü	ü
	3	2	2	ü	ü
	4	3	2	ü	ü
	5	3	3	ü	ü
	6	2	2	ü	ü
48 h	1	2	2
	2	2	2	ü	ü
	3	2	2	ü	ü
	4	2	2
	5	2	2	S,ü	ü
	6	3	2	S, ü	ü
72 h	1	2	2	S
	2	2	2	ü,S	ü
	3	2	2	ü,S	ü
	4	2	2	S
	5	2	2	ü, S	ü
	6	3	2	ü, S	ü
8 d	1	1	0	sS *
	2	1	0	S *
	3	1	0	sS *
	4	1	0	S *
	5	1	0	S *
	6	1	0	sS *
Mean 24h, 48h, 72 h	1	2	2
	2	2	2
	3	2	2
	4	2.3	2
	5	2.3	2.3
	6	2.6	2
Mean 24h, 48h, 72h	∑1 -6	2.21	2.05

Symbols:

K        - scab

ü    - finding extending the site of application

S        - desquamation

sS     - strong desquamation

*       - diagnostic findings of desquamation macroscopically and pathologically confirmed

Irritation scores for test performed on scarified skin:

Erythema: Mean (24h, 48h, 72h) of all animals: 2.28

Edema: Mean (24h, 48h, 72h) of all animals: 2.0