Valeraldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Valeraldehyde

EC Number:

203-784-4

EC Name:

Valeraldehyde

Cas Number:

110-62-3

Molecular formula:

C5H10O

IUPAC Name:

pentanal

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): n-Valeraldehyde
- Physical state: colorless, clear liquid
- Analytical purity: 98.5% (GC)
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: Tank 301/T 602
- Stability under test conditions: assumed stable
- Storage condition of test material: refrigerator, exclusion of light and oxygen (under nitrogen)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adults
- Weight at study initiation: 3.7, 3.65, and 3.7 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet (e.g. ad libitum): Kliba-laboratory animal diet, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): municipal tap water, ca. 250 mL per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12, 6:00 to 6:00

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: semiocclusive (Idealbinde from Pfaelzische Verbandstoff-Fabrik, Kaiserslautern, FRG) and Fixomull stretch (adhesive fleece) from Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.78

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

For animal 2 and 3, erythema and edema were extending beyond the area of exposure during the period of maximum irritation response (1 h to 72 h after removal of the patch)

Any other information on results incl. tables

Skin irritation effects resulting from administration of 0.5 mL of valeraldehyde to rabbits

 

Readings (time after removal of patch)	Animal 1		Animal 2		Animal 3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1h	2	0	2	2	2	1
24 h	1	0	3	1	2	1
48 h	0	0	3	1	2	0
72 h	sd	sd	3	1	2	0
7 d	sd	sd	2	1	1	0
14 d	sd	sd	2	0	0	0
Mean (24 - 72 h)	0.33	0	3	1	2	0.33

 

sd = study discontinued because the animal was free of symptoms

 

For animal 2 and 3, erythema and edema were extending beyond the area of exposure during the period of maximum irritation response (1 h to 72 h after removal of the patch)

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Erythema was noted starting from 1 h after removal of the patch (all 3 animals) up to 14 days (1 animal) with maximum scores of 3. Edema was less pronounced (only 2 animals, shorter period, maximum score of 2). Classification criteria of Directive 67/548/EEC and Regulation (EC) No. 1272/2008 are exceeded requiring classification of valeraldehyde as irritating to skin.

Executive summary:

In a primary dermal irritation study according to OECD test guideline 404 (Acute Dermal Irritation/Corrosion), three young adult male New Zealand White rabbits were dermally exposed to 0.5 mL of valeraldehyde (purity 98.5%) for 4 hours applied to a 2.5 x 2.5 cm clipped body surface area. Animals then were observed for 14 days. Irritation was scored according to the grading system of OECD test guideline 404 (method of Draize).

 

Erythema was noted starting from 1 h after removal of the patch (all 3 animals) up to 14 days (1 animal) with maximum scores of 3. Edema was less pronounced (only 2 animals, shorter period, maximum score of 2). Mean erythema and edema scores (24. 48, and 72 h, all animals) were 1.78 and 0.44 respectively. In this study, valeraldehyde was demonstrated to be a dermal irritant (BASF 1999).

 

This study is rated as acceptable. It satisfies the requirement of OECD Test Guideline 404 for skin irritation/corrosion.