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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:
1993-12-07 to 1993-12-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline 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)
GLP compliance:
yes
Remarks:
no certificate

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanal
EC Number:
203-957-4
EC Name:
Decanal
Cas Number:
112-31-2
Molecular formula:
C10H20O
IUPAC Name:
decanal
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C10
- Substance type: Clear liquid
- Physical state: Liquid
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 93/10/02
- Expiration date of the lot/batch: 1994-04
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK) Ltd, Petersfield, Hampshire, United Kingdom
- Age at study initiation: 11 to 13 wks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: Individually in cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) rabbit diet ad libitum (not analysed)
- Water: Ad libitum
- Acclimation period: Yes

ENVIRONMENTAL CONDITIONS
- Temperature: Approx. 19 °C
- Humidity: 30 to 70 %
- Air changes: Approx. 19 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.5 mL
Duration of treatment / exposure:
4 hr
Observation period:
11 d
Number of animals:
3
Details on study design:
TEST SITE
- 24 hr prior to application, approx. 100 mm x 100 mm site on dorso-lumbar region clipped with electric clippers.
- Test substance applied under a 25 mm x 25 mm gauze pad to 1 intact skin site on each animal.
- Each site covered with an Elastoplast elastic adhesive dressing for 4 hrs.
- The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing at end of exposure period with warm water (30 to 40 °C) to remove any residual test substance. Test area then blotted dry with absorbant paper.

SCORING SYSTEM:
- Erythema
-- 0: No erythema
-- 1: Very slight erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading
- Oedema:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well-defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Desquamation observed on days 7-10
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1.33
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Blanching observed on days 8 and 8. Hardening of the skin observed on day 9. Desquamation observed on day 10
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
3
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: Desquamation observed on days 7-10
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 11 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1
Remarks on result:
other: Hardening of the skin observed on day 10
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72h
Score:
2
Reversibility:
fully reversible within: 11 d
Irritant / corrosive response data:
The numerical values given to the dermal reactions elicited by Aldehyde C10 are shown in Table 1.

Well-defined to moderate erythema with very slight or slight oedema developed in all three animals. In two animals these reactions were accompanied by desquamation of the stratum corneum from Day 7. Blanching, hardening of the skin and desquamation of the stratum corneum was seen in the third animal. The reactions gradually ameliorated and had resolved completely by day 11.

Any other information on results incl. tables

Table 1: Dermal reactions observed after application of Aldehyde C10

Rabbit number and sex

E = Erythema

O = Oedema

Day

1

2

3

4

5

6

7

8

9

10

11

2801

E

O

1

0

2

1

2

1

2

1

2

1

2

1

a2

1

a2

1

a1

1

a1

1

0

0

2802

E

O

1

0

2

1

1

1

1

1

2

1

2

1

b3

`1

b2

1

c1

1

a1

c1

0

0

2803

E

O

2

1

2

2

2

2

2

2

3

2

2

2

a2

2

a2

2

a1

1

a1

1

0

0

* Approximately 30 minutes after removal of the dressing

a Desquamation of the startum corneum

b Blanching

c Hardening of the skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for skin irritation according to OECD EU Method B.4. Under the conditions of the test, the test substance was not shown as irritating and therefore is not considered to be classified as irritating to skin according to CLP Regulation No (EC) 1272/2008.