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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:
Sep 2015 - Jan 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

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)
Qualifier:
according to guideline
Guideline:
other: JMAFF Guidelines (2000)
Version / remarks:
including the most recent revisions
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium rac-1-hydroxy-3-(quinolin-6-yl)propanesulfonate
Cas Number:
1609934-65-7
Molecular formula:
C12H12NO4SNa
IUPAC Name:
Sodium rac-1-hydroxy-3-(quinolin-6-yl)propanesulfonate
Test material form:
solid: particulate/powder

Test animals

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

Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40
to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these
conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany,
dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy)
approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden
sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study
period.
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed
according to facility standard procedures. There were no findings that could interfere with the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Three rabbits were exposed to 0.5 grams of INC280-C1, 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:
4 hours exposure to INC280-C1.
Observation period:
1, 24, 48 and 72 hours after exposure.
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 four days later, after considering the
degree of skin irritation observed in the first animal.

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:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to INC280-C1. There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin by the test item was observed and no test item remnants were seen. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results INC280-C1 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).