Registration Dossier
Registration Dossier
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EC number: 204-464-7 | CAS number: 121-32-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From may 2003 to 28 august 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-ethoxy-4-hydroxybenzaldehyde
- EC Number:
- 204-464-7
- EC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
- Cas Number:
- 121-32-4
- Molecular formula:
- C9H10O3
- IUPAC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.4 +/- 0.2 kg
- Housing: individually in polystyrene cages (48.2*58*36.5 cm)
- Diet (e.g. ad libitum): free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From: 27 may 2003 To: 30 may 2003
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control on the other untreated flank
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: on one flank
- Type of wrap if used: the test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated
semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test item was miped off by means of a moistened cotton pad.
SCORING SYSTEM: according to the Commission Directive 2004/73/EC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- yellow coloration of the skin
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
1/1/0 |
0/0/0 |
24 h |
1/1/0 |
0/0/0 |
48 h |
1/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.7/0.3/0 |
0/0/0 |
Reversibility |
Yes at 72 hours |
/ |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating.
- Executive summary:
In one primary dermal irritation study of validity 1 (Klein, 2003), young adult New Zealand White rabbits (3 males) were dermally exposed to 500 mg of ethylvanillin onto one flank. Test sites were covered with semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours.
Irritation was scored by the method of the Commission Directive 2004/73/EC. Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.3 and 0 for erythema and 0, 0 and 0 for edema.
In this study, ethylvanillin is very slightly irritant when applied topically to rabbits, but not classified according to the EU classification criteria.
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