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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:
03 Apr - 06 Apr 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
adopted in 1998
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2008
GLP compliance:
yes (incl. certificate)
Remarks:
GYEMSZI, National Institute for Quality- and Organizational Development in H ealthcare and Medicine, Budapest, Hungary

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S&K-Lap Co.Ltd., Kartal, Hungary
- Age at study initiation: 13 - 14 weeks
- Housing: individually in AAALAC approved metal wire rabbit cages
- Diet: UNI diet for rabbits (Agribands Europe Hungary PLC, Karcag, Hungary), ad libitum
- Water: tap water from the municipal supply, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.8 - 20.9
- Humidity (%): 24 - 56
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
approximately 24 h before application
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:
Initially, a single animal was treated for 1 h. As no significant irritant effect was observed after the 1 h exposure, the test was completed using the 2 remaining animals with an exposure period of 4 hours.
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 10 x 10 cm²
- Type of wrap: the test material was held in contact with the skin by gauze pads dampened with water to ensure good contact with the skin. An adhesive hypoallergenic plaster kept the gauze pads in contact with the skin. The entire trunk of the animals was then wrapped with plastic wrap with an elastic stocking.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with lukewarm water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h

SCORING SYSTEM:
- Method of calculation: numerical scoring system listed in the Commission Directive 2004/73/EC 2004 which is based on the Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Very slight erythema (score 1) was noted in all animals at 1 h after patch removal and very slight erythema (score 1) was noted in two rabbits 24 hours after patch removal.
Other effects:
- Other adverse local effects: At the observation time points, 48 and 72 h after patch removal, there were no local signs on the skin of the treated animals.
- Other adverse systemic effects: No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified