Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
study acc. to OECD 404 conducted in 2013
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 of November till 13 of December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted and well documented study under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

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

Test material

Constituent 1
Reference substance name:
ZnHBED
IUPAC Name:
ZnHBED
Constituent 2
Chemical structure
Reference substance name:
disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
Cas Number:
1263416-97-2
Molecular formula:
C20 H20 N2 Na2 O6 Zn
IUPAC Name:
disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The experiment was conducted on three males: 8-month-old – rabbit No. 1, 7-month-old – rabbit No. 2 and 6.5-month-old No. 3.
The rabbits were quarantined and observed daily for 5 days. A general medical-veterinary examination was performed on the day of the introduction of the animals to the quarantine, whereas a detailed medical-veterinary examination was performed prior to the beginning of the experiment. Only animals without any pathological signs were introduced to the experiment. They were randomly selected to it and marked individually.

Housing conditions
During the quarantine and the experiment, the animals were kept in air-conditioned rooms under the following conditions:
- air temperature: 20 - 22C
- relative air humidity: 45 – 65%
- artificial fluorescent lighting; lighting cycle: 12 hours light/12 hours dark
- facility air exchange: about 16 times/h [SOP/T/9].
The animals were individually housed in metal cages. The dimensions of the cages were 60 x 35 x 40 cm (length x width x height). Each cage was equipped with a label containing the number of the study protocol, the dates of the experiment commencement and termination (written after the termination), and sex and number of the animal.

Food and water
The animals were given ad libitum access to the "LSK" standard granulated laboratory fodder and drinking tap water.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
The test item in a amount of 0.5 g was applied on the prepared skin of rabbits.
Duration of treatment / exposure:
4 h
Observation period:
General clinical observations of all animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin for erythema, edema, and other pathological changes were performed 1, 24, 48, and 72 hours after the end of the treatment.
Number of animals:
3
Details on study design:
The study commenced with a sighting study on one animal. The test item in a amount of 0.5 g was applied once to the shaved skin of one animal (rabbit No. 1) and covered with an appropriate band. The exposure lasted 4 hours. After evaluation of treated skin, in order to confirm irritation or its absence, the test item was applied to the skin of the next two animals (rabbit No. 2 and No. 3) for 4 hours in order to confirm its irritant properties. The procedure was the same as in case of rabbit No. 1. General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48, and 72 hours after the end of the exposure.
Body weights of the animals were determined on the administration day (day 0), i.e. directly before the administration, and on the last day of the experiment. After the observation period, the animals were euthanized.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1h, 24h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h, 24h, 48h, 72h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h, 24h, 48h, 72h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h, 24h, 48h, 72h
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
The observations of the treated skin revealed some changes in the form of erythema. No any ohers effect were observed (no mortality, edema and any other clincal sign).
Other effects:
No any ohers effect were observed.

Any other information on results incl. tables

Zn (II) HBED: Acute skin irritation/corrosion study on rabbits

Administered volume of the test item

0.5 mL

Animal number

1

2

3

Sex

male

male

male

Mortality

0/1

0/1

0/1

General clinical signs

none

none

none

Skin erythema in the treatment area

very slight (barely perceptible) after 1 hour and 24 hours

very slight (barely perceptible) after 1 hour

very slight (barely perceptible) after 1 hour

Skin edema in the treatment area

none

none

none

Other

none

none

none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The assessed substance ZnHBED does not irrite skin.
Executive summary:

On the grounds of the study, the test item, i.e. Zn (II) HBED can be classified to the following categories: - does not irritate the rabbit skin – according to the Annex to the Decree of the Minister of Health of August 10, 2012 on classification of chemical substances and mixtures (Journal of Laws, item 1018), - is beyond categorization – according to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling, and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006.