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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 2013 - March 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
Cas Number:
571188-59-5
Molecular formula:
C14H22N4O2
IUPAC Name:
tert-butyl 4-(6-aminopyridin-3-yl)piperazine-1-carboxylate
Test material form:
solid: bulk

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 Males. At start of dosing, the animals were between 12 and 24 weeks old and body weights were at least 1.5 kg.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.6 mL of the vehicle and applied to the skin of one flank, using a metalline patch# of 2x3 cm.
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
Number of animals:
3
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 6 days later, after considering the degree of skin irritation observed in the first animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation.
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation.
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No skin irritation.
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1. Irritation
No skin irritation was caused by 4 hours exposure to LEE011-A2.
2. Corrosion
There was no evidence of a corrosive effect on the skin.
3. Coloration / Remnants
No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
4. Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
other: LEE011-A2 does not have to be classified and has no obligatory labelling requirement for skin irritation
Conclusions:
Based on these results LEE011-A2 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 (2011) (including all amendments),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).