Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14/06/2011-19/06/2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) N.440/2008, L142, Annex Part B
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art.9.2, N.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
TEST ANIMALS
- Source: Charles River Deutchland
- Age at study initiation: approximately 36 weeks old
- Weight at study initiation: > 2 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10x/ hour
- Photoperiod (hrs dark / hrs light): artificial light, 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
The test item was held in contact with the skin throughout a 4-hour period.
Animal N.1: It was not necessary to remove any residual test item at the end of the exposure period.
Animal N.2 and 3: At the end of the exposure period, the residual test item was removed with tap water.
Observation period:
All animals were observed for 72 hours after the patch removal.
Number of animals:
3

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:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, the single dermal application of the test item (ELV)DIARIL CHETONE to 3 rabbits at a dose of 0.5 g showed neither irritant or corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex VI of Commission Directive 2001/59/EC and Annex I of regulation 1272/2008, the test item (ELV)DIARIL CHETONE does not have to be classified and has no obligatory labelling requirement for skin irritation.