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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:
Experimental start date: 26 January 2016 Experimental completion date 12 February 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
OECD Guideline for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 28 July 2015)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
other: yellow semi-solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
New Zealand White (Hsdlf:NZW)
Details on test animals and environmental conditions:
Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK. At the start of the study the animals weighed 2.69 or 4.00 kg and were 12 to 20 weeks old. After an acclimatization period of at least 5 days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A quantity of 0.5 mL of the test item was applied directly to the skin
Duration of treatment / exposure:
Four hours
Observation period:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
Number of animals:
3
Details on study design:
Please see below

Results and discussion

In vivo

Results
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
mean
Time point:
24/48/72 h
Score:
1.23
Max. score:
2
Reversibility:
not fully reversible within:
Remarks on result:
other: The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema
Remarks:
Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation. At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.
Irritant / corrosive response data:
Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation.

At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.

Any other information on results incl. tables

Skin Reactions

 

The individual scores and mean scores for erythema/eschar and edema are given in the attached Appendix 1.

 

Very slight erythema, with or without very slight edema, were noted at all treated skin sites immediately after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at two treated skin sites 1 hour after patch removal. Well-defined erythema and slight edema were noted at one treated skin site and very slight erythema, with or without very or slight edema, were noted at two treated skin sites at the 24 and 48-Hour observations. Well-defined erythema and very slight edema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 72-Hour observation.

 

At the 72-Hour observation, light brown discoloration of the epidermis and loss of skin elasticity were also noted at one treated skin site and slight desquamation was noted at one other treated skin site. Slight desquamation and glossy skin were noted at one treated skin site at the 7-Day observation.

 

The third treated skin site appeared normal at the 72-Hour observation and one of the initial treated skin sites appeared normal at the 7-Day observation.

 

BodyWeight

 

Individual body weights and body weight change are given in the attached Appendix 2. All animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema and 1.7, 1.0 and 0.3 for edema.
Executive summary:

Introduction

 The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

 Results

A single 4-Hour, semi occluded application of the test item to the intact skin of three rabbits produced very slight to well-defined erythema and very slight to slight edema. Other skin reactions noted were light brown discoloration of the epidermis, loss of skin elasticity, slight desquamation and glossy skin. One treated skin site appeared normal at the 72-Hour observation and one other treated skin site appeared normal at the 7-Day observation. No corrosive effects were noted.

 

Conclusion

 The test item produced individual mean scores of 2.0, 1.0 and 0.7 for erythema and 1.7, 1.0 and 0.3 for edema.