Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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,
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

Applicant's summary and conclusion