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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:
10/03/02 - 10/18/02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No certificate of analysis.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Simplied study.
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Vanillic acid
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
- Stability under test conditions: yes

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: New Zealand White rabbits (Oryctolagus cuniculus)
- Sex: males and females.
- Sources: Millbrook Breeding Labs, Amherst, MA.
- Age at study initiation: at least 10 weeks old (adult)
- Weight at study initiation: 2.05 - 2.31 kg.
- Housing: individual housing, in suspended stainless steel.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30 to 70%
- Air changes: 10 TO 15
- Photoperiod: 12 hrs dark / 12 hrs light

I

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Concentration: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: a surface of about 6 cm2
- % coverage: no data
- Type of wrap: a surgical gauze measuring 25X25 mm.


REMOVAL OF TEST SUBSTANCE
- Washing: the bandages were removed and if necessary excess test substance which had not penetrated was wiped away with a gauze pad moistened with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: based on erythema and oedema formation, according to directive OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, Vanillic acid is not considered as irritating to skin and not classified according to EU criteria.
Executive summary:

In a dermal irritation study (Comparable to OECD 404, GLP), three New-Zealand White rabbits were dermally exposed to 0.5 mL of vanillic acid on a 6 cm2 body surface area. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 3 days. Irritation was scored by the method of OECD guideline 404.

The mean scores (24, 48 and 72 hours) for both oedema and erythema were 0.0 for all animals. Under the test conditions of this study, Vanillic acid is considered as not irritating to skin and therefore not classified according to EU criteria.