Registration Dossier

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 2007-02-20 to 2007-03-16
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EEC
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
Batch no: EZ06-B001;

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Cage type: Animals were housed in Macrolon cages, size III., with 3 or 2 animals/cage (42 x 42 x 19 cm)
Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasern
Produced by: SSNIFF Specialdiaten GmbH, Ferd.-Gabriel-Weg 16, 59494 Soest
Light: 12 hours daily from 6 a.m. to 6 p.m. (artificial light)
Ventilation: 8-12 air exchange/hour by central air-condition system.
Temperature: 20 * 3 °C
Relative humidity: 30-70 %

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
NA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Remarks on result:
other: end of experiment
Irritant / corrosive response data:
After 1 h in one animal very slight erythema appeared on the treated skin surface (score 1).
Other effects:
During the study the general state and behaviour of animals were normal. There were no notable body weight changes during the contact and
observation period.

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
AVE 5530 EVA-KET is not a skin irritant.
Executive summary:

According to EEC directive 2001/59/EEC the classification of the test item AVE 5530 EVA-KET is not a skin irritant.