Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June to July 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD, EPA, etc)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XP-7866
- Substance type: White powder
- Physical state: Solid
- Analytical purity: 99.5 wt% obtained by H-NMR
- Purity test date: 99.5 wt%
- Lot/batch No.: 10188-1 JM
- Expiration date of the lot/batch: February 28, 2015
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: New Zealand White (Hsdlf:NZW) strain rabbits, supplied by Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: twelve to twenty weeks old at the start of the study.
- Weight at study initiation: 2.06 to 2.79 kg at the start of the study.
- Housing: Animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Rate of air changes (per hr): Fifteen changes per hours
- Photoperiod (hrs dark / hrs light): 12h/12h light/darkness (0.6:00 to 18:00)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.

Note:
* The absorption of the test item was not determined.
*The pH of the test item was determined prior to commencement of the study. the pH was for a preparation of 10% w/w aqueous preparation of the test item: 7.3 immediately and 7.6 after 10 minutes.
Duration of treatment / exposure:
- One rabbit initially treated: on this rabbit, 3 suitable sites were selected. One patch was removed at each of three time points: 3 minutes, 1 hours and 4 hours after application.
- Two additional rabbits: 1 site during 4 hours.
Observation period:
1, 24, 48 and 72 hours after the removal of the patches
Number of animals:
3 rabbits used
Details on study design:
TEST SITE
- Area of exposure: Test item introduced under a 2.5 cm x 2.5 cm cotton gauze patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

EVALUATION OF SKIN REACTIONS
- Erythema and Eschar Formation
* No erythema: 0
* Very slight erythema (barely perceptible): 1
* Well-defined erythema: 2
* Moderate to severe erythema: 3
* Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
- Oedema Formation
* No oedema: 0
* Very slight oedema (barely perceptible): 1
* Slight oedema (edges of area well-defined by definite raising): 2
* Moderate oedema (raised approximately 1 millimetre): 3
* Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Male 70638
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Male 70659
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Male 70661
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Male 70638
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Male 70659
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Male 70661
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable in the case of the experiment
Irritant / corrosive response data:
The test item is not irritant to the skin according to the current experiment.
No corrosive effect has been recorded.

Any other information on results incl. tables

All animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item has produced no observation on none of the 3 animals tested and at any time. According the results, the test item will not be classified based on the criteria fixed by the REGULATION (EC) No 1272/2008 on 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. The method was designed to be compatible with the following:

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal

Irritation/Corrosion" (adopted 24 April 2002)

• Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC)

No. 440/2008

Results.

* 3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.

* A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.

Conclusion.

The test item has produced no observation on none of the 3 animals tested and at any time. According the results, the test item will not be classified based on the criteria fixed by the REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.