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EC number: 204-646-6 | CAS number: 123-72-8
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-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:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- 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
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Mean value
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Mean value
- 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
- 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
- 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 |
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.
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