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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:
1988-07-05 to 1988-07-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study without deviations
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible
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.