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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Vazo(R) 56 WSP
- Substance type: organic
- Physical state: solid
- Analytical purity: > 97 %
- Lot/batch No.: M0200
- Expiration date of the lot/batch: Not advised, but assumed to be stable for six months from date of receipt
- Storage condition of test material: stored at room temperature in the dark from date of receipt and at 4 °C in the dark from 10 December 1998

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.5 to 3.3 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Special Diet Services STANRAB (P) SQC pellet
- Water (e.g. ad libitum): Anglian Water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18- 19 °C
- Humidity (%): 28 to 43 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
moistened with 05. ml distilled water
Duration of treatment / exposure:
four hours
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 mm * 25 mm
- Type of wrap if used: gauze pad, Elastoplast elastic adhesive

REMOVAL OF TEST SUBSTANCE
- Washing : warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 Hour
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of Vazo(R) 56 WSP to intact rabbit skin for four hours elicited no dermal irritation.