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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 December 1993 to 20 December 1993.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Aldehyde C8
IUPAC Name:
Aldehyde C8
Constituent 2
Chemical structure
Reference substance name:
Octanal
EC Number:
204-683-8
EC Name:
Octanal
Cas Number:
124-13-0
Molecular formula:
C8H16O
IUPAC Name:
octanal
Test material form:
other: clear liquid
Details on test material:
- Name of test material (as cited in study report): Aldehyde C8

- Physical state: Clear Liquid
- Analytical purity: 98.6%

- Lot/batch No.: 93/10/02
- Expiration date of the lot/batch: April 1994

- 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
- Source: Froxfield (U, K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 11 to 13 weeks of age
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Housed individualIy In metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: Animals were acclimatised but no indication of length of acclimatisation.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C
- Humidity (%): 30 -70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours dark

IN-LIFE DATES: From: 7 December 1993 to 20 December 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: An area approximately 100 x 100mm was shaved on the dorso-lumbar region of each rabbit. a 25 x 25 mm test site within this area was used for application
- % coverage: Not documented
- Type of wrap if used: Semi-occlusive Elastoplast elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: Immediately after bandage removal at the end of the 4 h exposure period

Reactions were scored according to a modified Draize system:
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)
preventing erythema reading 4

Oedema formation:
No oedema o Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than I millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
1.6
Max. score:
2
Reversibility:
no data
Remarks on result:
other: Some blanching and hardening of the skin was observed.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
2
Max. score:
3
Reversibility:
no data
Remarks on result:
other: Some necrosis, blanching of the skin, hardening of the skin and new skin formation was observed.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
2.1
Max. score:
3
Reversibility:
no data
Remarks on result:
other: Some blanching and hardening of the skin was observed.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
1.1
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks:
12 days
Remarks on result:
other: Some hardening of the skin was observed on Day 7
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
2.1
Max. score:
3
Reversibility:
fully reversible
Remarks:
13 days
Remarks on result:
other: Some hardening of the skin was observed on days 8, 9 and 10.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: erythematous reactions persisted in all three rabbits at termination after 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.44
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: reactions were reversible in only two of three rabbits. Oedema was present for all three until 11 days after dosing
Irritant / corrosive response data:
Well-defined to moderate erythema with slight to moderate oedema developed in all three animals and was accompanied by blanching and hardening of the skin. These reactions gradually ameliorated and new skin was seen on one animal from day 12. The erythematous reactions persisted to termination in all three treated rabbits.
Other effects:
No additional information provided

Any other information on results incl. tables

Dermal Reactions observed following application of Aldehyde C8

Rabbit number

E=Erythema

O=Oedema

Day

 

 

1*

2

3

4

5

6

7

8

9

10

11

12

13

14

1

E

O

2

2

b2

2

b2

1

b2

1

b2

1

b2

1

b2

1

b2

1

c2

1

c1

1

c1

1

c1

1

c1

1

c1

1

2

E

O

a1

1

b2

1

b2

1

b2

1

b2

1

c3

2

b3

c2

c3

2

c3

2

c2

2

c2

2

d1

0

d1

0

d1

0

3

E

O

2

2

b2

2

b2

2

b2

2

b3

3

b3

3

b3

3

b3

c3

b2

c3

b2

c2

c2

2

c2

2

c1

0

c1

0

* Approximately 30 minutes after removal of the dressing

a Necrotic edge

b Blanching

c Hardening of the skin

d New skin.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance Aldehyde C8 was considered to be irritating to intact rabbit skin.
Executive summary:

In a study conducted in 1994, the test substance Aldehyde C8 was examined for its ability to cause skin irritation when tested on intact rabbit skin. The dorso-lumbar regions of each animal were shaved approximately 24 hours prior to the start of the study. 0.5 mL of undiluted test substance was applied under a gauze pad to one intact skin site on each animal and a semi-occlusive dressing was applied over it. The dressing was left in place for 4 hours before being removed and the test area wiped clear of any residual test substance. The skin reactions of each test animal were observed for 14 days. Well-defined to moderate erythema with slight to moderate oedema developed in all three animals and was accompanied by blanching and hardening of the skin. These reactions gradually ameliorated and new skin was seen on one animal after 12 days. Under the conditions of this study, the test substance Aldehyde C8 was considered to be irritating to intact rabbit skin. Based on these results, the test substance should be classified as a Category 2 skin irritant and should have the signal word Warning and the hazard statement H315: Causes skin irritation associated with it in accordance with Regulation EC No. 1272/2008.