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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:
2002-05-22 until 2002-08-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan , Horst, The Netherlands
- Weight at study initiation: 1.8 - 1.9 kg
- Age: At least 6 weeks old
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30-70 % rel. humidity
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated but shaved other side served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g in 0.3 ml water

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: patch held with an non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritating to the skin of rabbits
Executive summary:

The irritation study on three New Zealand White Rabbits with 0.5 g of Cavasol W6 HP dosed semiocclusively with in 0.3 ml of water did not show any seigns of irritating effects within the observation period. No other signs of toxicity were found.