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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 14, 2001 till August 23, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identity: ZP-TIX 1014
Purity > 99%
Batch number: NW-01-028
Expiry date: 30.12.2001
Description: solid
Stability of test item: Stable under storage conditions
Storage conditions: in the original container, at room temperature ( range of 17-23°C), away from direct sunlight
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source of rabbits: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalarone (France)
Number of animals per test: 3 (Animals of both sexes were used)
Age: 11-12 weeks (male), 10-12 weeks (female)
Acclimatization: Under laboratory conditions after health examination. Only healthy animals (judged by visual signs) were used.
Conditions: Standard Laboratory Conditions
Accomodation: Individually in stainless stell cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (bact no. 91/01) and haysticks (QS no. 74/01) provided by Eberle Nafag AG, CH-9200 Gossau.
Water: Community tap water from Füllingsdorf, Switzerland.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5mg/animal, moistened with approximately 0.1 ml bi-distilled water before application
Duration of treatment / exposure:
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean th application site so that any reactions (erythema) were clearly visible at that time.
Observation period:
72 h

Number of animals:
3 per test

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
ca. 0
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: max. score was reached after one hour and not present anymore at 24hours
Other effects:
No other effects.
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

Animal Number Sex Evaluation Interval Erythema Oedema
42 M 1 hour 1 0
43 F 1 0
44 F 1 0
42 M 24 hours 0 0
43 F 0 0
44 F 0 0
42 M 48 hours 0 0
43 F 0 0
44 F 0 0
42 M 72 hours 0 0
43 F 0 0
44 F 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the reffered classification criteria (EEC Commission Directive 93/21/EEC of April 27,1993), ZP-TIX 1014 is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of ZP-TIX 1014 was investigated by topical semiconclusive application of 0.5g to 6cm² intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

Very slight erythema was observed at the test site of all animals 1 hour after treatment.

The test item did not however elicit any skin reactions at the application site of any animal at the 24 -, 48- or 72 hour readings. The mean values from 24 to 72 hours were therefore 0 for erythema an 0 for oedema.

The test item caused no staining of the treated skin.

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21/ EEC of April 27,1993, ZP-TIX 1014 is considered to be "not irritating" to rabbit skin.