Butyraldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-07-05 to 1988-07-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study without deviations

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyraldehyde

EC Number:

204-646-6

EC Name:

Butyraldehyde

Cas Number:

123-72-8

Molecular formula:

C4H8O

IUPAC Name:

butanal

Details on test material:

- Name of test material (as cited in study report): n-Butanal
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): 72.1 g/mol
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: colourless liquid
- Analytical purity: ca. 99%
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: IDBY 205
- Expiration date of the lot/batch: Not documented
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: In the dark at 20°C
- Other: Not documented

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Toxicology, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.0 - 2.7 kg bw
- Housing: single in cages, acclimatised room
- Diet (e.g. ad libitum): Altromin 2123 ad libitum
- Water (e.g. ad libitum): deionised chlorinated water from automatic drinkers ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: Not documented

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

30-60min, 24, 48 and 72 h
if necessary 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25cm2 dorsal area of the trunk
- % coverage: Not documented
- Type of wrap if used: semi occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was washed with lukewarm tap water.
- Time after start of exposure: 4 after the start of exposure.

SCORING SYSTEM:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: Mean value

Other effects:

No further information

Any other information on results incl. tables

Results of skin irritation study
Observation time	1		2		3
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1 h	2	0	2	0	1	0
24 h	0	0	2	0	2	1
48 h	0	0	1	0	1	0
72 h	0	0	1	0	2	0
Mean value 24 + 48 + 72 h	0.00	0.00	1.33	0.00	1.67	0.33
Reversibility	Yes	Yes	Yes	Yes	Yes	Yes

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No classification
Based on GHS, no classification required

Executive summary:

In a valid standard guideline study using 3 rabbits according to OECD 404 and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion), semiocclusive exposure of 4 h to undiluted butyraldehyde (0.5 ml) produced slight skin irritation: One through 72 hours after removal of the cover, barely perceptible (score 1) to distinct erythemas (score 2) were observed in all animals with a slight oedema in one animal after 24 h (score 1). All these effects subsided within 1 d in 1/3 animals and within 7 d in 2/3 animals, while the treated skin sites was still slightly scaly at this time.