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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:
2013-03-20 to 2013-05-07
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:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Batch no. 1111002378

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
EXPERIMENTAL ANIMALS:
- Species: New Zealand White rabbits
- Source: S&K-LAP Kft, 2173 Kartal, Császár út 135, HUNGARY
- Age of animals at treatment: ~12 weeks old
- Sex: Male
- Body weight range at the beginning of the in-life phase: 3211–3394 g, at the end of the in-life phase: 3278–3491 g

HUSBANDRY:
- Lightning periods: 12 hours daily
- Temperature during the study: 17.1 19.5 °C
- Relative humidity during the study: 24–56%
- Air changes: 15-20/h
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.

FOOD and FEEDING:
- Animals received UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum.

WATER SUPPLY:
- Animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Animals were their own control
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
Observation at 1, 24, 48, 72 hours after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: full
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Relevant
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

At observation one hour after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 24 hours after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 48 and 72 hours after patch removal, no clinical signs were noted on the skin of the treated animals. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively. The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute skin irritation study (OECD 404) Puramex Zn was not irritating to the skin of New Zealand White rabbits.
Executive summary:

An acute skin irritation study was performed with Puramex Zn in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No. 404, 2002). An amount of 0.5 g of the test item was applied to the skin of the test animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rabbits. These gauze pads were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After 4 hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48, and 72 hours after the patch removal. Additional general examinations were performed daily. There was no mortality during the observation period. There was no test item related effect on body weight. At observation one hour after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 24 hours after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 48 and 72 hours after patch removal, no clinical signs were noted on the skin of the treated animals. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively. The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

According to Directive 2001/59/EC, Puramex Zn does not require classification as a skin irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Puramex Zn does not require classification as a skin irritant. According to the classification system based on the scheme devised by Draize (1959), Puramex Zn is a "non-irritant".