[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 25 February 2014 to 28 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 65088/A TE
Batch: CUF 176, 3011 SCE 346
Purity: 93.8% w/w
Physical state / Appearance: light yellow powder
Expiry date: 29 September 2017
Storage Conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.37 or 2.57 kg and were twelve to twenty weeks old. After an acclimatization period of at least five 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 Harlan Laboratories UK Ltd., 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 twelve hours continuous light (06:00 to 18:00) and twelve 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:

other: The test material was moistened with 0.5 ml of distilled water.

Controls:

no

Amount / concentration applied:

0.5 g of the test item.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

2 rabbits

Details on study design:

On the day before the test two rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

On the day of the test a suitable test site was selected on the back of each rabbit. At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water to achieve a paste, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.

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 and scored according to the Evaluation of skin reactions (see table below).

Any other skin reactions and clinical signs of toxicity, if present, were also recorded.

Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal #1

Remarks:

73978 Male

Time point:

other: Mean score at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1hour

Remarks on result:

other: Non-irritant

Results 2

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal #2

Remarks:

73979 Male

Time point:

other: Mean score at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 hour

Remarks on result:

other: Non-irritant

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

73978 Male

Time point:

other: Mean score at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 hour

Remarks on result:

other: Non-irritant

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

73979 Male

Time point:

other: Mean score at 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 hour

Remarks on result:

other: Non-irritant

Irritant / corrosive response data:

Skin Reactions

The individual scores for erythema/eschar and edema are given in Table 1.
Very slight erythema and very slight edema were noted at both treated skin sites immediately after patch removal.
Both treated skin sites appeared normal one hour after patch removal.

Other effects:

Body Weight

Individual body weights and body weight change are given in Table 2.
Both animals showed expected gain in body weight during the study

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Skin Reaction	Observation Time (following patch removal)	Individual Scores – Rabbit Number and Sex		Total
		73978Male	73979Male
Erythema/Eschar Formation	Immediately	1	1	(2 )
	1 Hour	0	0	( 0 )
	24 Hours	0	0	0
	48 Hours	0	0	( 0 )
	72 Hours	0	0	0
Edema Formation	Immediately	1	1	( 2 )
	1 Hour	0	0	( 0 )
	24 Hours	0	0	0
	48 Hours	0	0	( 0 )
	72 Hours	0	0	0
Sum of 24 and 72‑Hour Readings (S) :        0
Primary Irritation Index (S/4)              :        0/4 = 0.0
Classification                                       :        NON‑IRRITANT

(   ) =    Total values not used for calculation of primary irritation index

Table 2: Individual Body Weights and Body Weight Change

Rabbit Number and Sex	Individual Body Weight (kg)		Body Weight Change (kg)
	Day 0	Day 3
73978 Male	2.37	2.43	0.06
73979 Male	2.57	2.68	0.11

Interpretation of Results:

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

 The scores for erythema and edema at the 24 and 72‑Hour readings were totaled for the two test rabbits (8 values) and this total was divided by 4 to give the primary irritation index of the test item. The test item was classified according to the following scheme devised byDraize, J.H. (1959):

 

Primary Irritation Index	Classification of Irritancy
0	Non-irritant
> 0 to 2	Mild irritant
> 2 to 5	Moderate irritant
> 5 to 8	Severe irritant

 

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.

 

The results were also interpreted according to Regulation (EC) No 1272/2008, relating to the Classification, Labeling and Packaging of Substances and Mixtures.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced a primary irritation index of 0.0 and was classified as non irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

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 two rabbits produced very slight erythema and very slight edema immediately after patch removal. Both treated skin sites appeared normal one hour after patch removal.

 

Conclusion

The test item produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

 

The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.