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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:
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:
2003
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

Constituent 1
Chemical structure
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

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.