Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.01.2008 to 24.07.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Species: Albino rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD)
Source: Harlan France SARL, Gannat, France.
Source: Harlan, Horst, The Netherlands.
Number of animals: 3 Males
Age and body weight: Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification: Earmark
Health inspection: A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of
health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
Three rabbits were exposed to 0.5 grams of DCM, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing.Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
Duration of treatment / exposure:
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square
centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.4 ml of the vehicle
and applied to the skin of one flank, using a metalline patch' of 2x3 em. The patch was mounted on Micropore tape•, which was wrapped
around the abdomen and secured with Caban elastic bandage•. Four hours after the application, the dressing was removed and the skin
cleaned of residual test substance using tap water.
•. Suppliers: Lohmann GmbH, Neuwied, Germany (Metalline) and 3M, St. Paul, Minnesota, U.S.A. (Micropore and Caban).
After the final observation, the animals were sacrificed by intra-venous injection of pentobarbital Euthesate® (Ceva Sante Animale BV,
Naaldwijk, The Netherlands).
Observation period:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal
served as controls.
Number of animals:
3 Males
Details on study design:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in
a similar manner 3 weeks later, after considering the degree of skin irritation observed in the first animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
None
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results DCM does not have to be classified and has no obligatory labelling requirement for skin irritation according to the
Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification
and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).