Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.05 - 27.06.2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well-documented GLP-Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: microgranules

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three white rabbits of New Zealand strain coming from conventional Reproductive Farm of Rabbits, Balice were used in the test.
The rabbits were quarantined for at least 5 days and observed carefully during this time.
One 5.5-month-old male rabbit weighing 4,02 kg and two 6 and 5-month-old female rabbits weighing 2.99 kg and 3.11 kg were used in the study.

During quarantine and experiment the animals were kept in air-conditioned rooms with the following parameters:
- temperature: 18 - 22 °C;
- relative air humidity: 50 - 80%;
- artificial fluorescent lighting: 12 hours light / 12 hours darkness.
The animals were kept individually in metal cages with dimensions: 60 x 35 x 40 cm. Each cage was equipped with label containing information on study protocol number, start date of the experiment, sex and animal number.

The animals were given ad libitum standard granulated fodder "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz and drinking tap water.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g unchanged test material
Duration of treatment / exposure:
4 hours
Observation period:
Observations of skin were performed after 1, 24, 48 and 72 hours as well as 7 days since the end of exposure.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: about 6 cm2.
- Type of wrap if used: The
gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbit’s trunk was covered with lignin and elastic bandage was used to make circular protecting band.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours of exposure, the band and gauze patches were taken off and the residual test material was removed using water.
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
During observation after 1 hour since the end of exposure, faint erythema (barely visible) was stated on treated skin of all three rabbits.
During observation after 24 hours since the end of exposure, faint erythema (barely visible) was stated on treated skin of rabbits No 1 and 2. No pathological changes on skin of rabbit No 3 were noticed.

During observation after 48 and 72 hours since the end of exposure faint erythema (barely visible) was observed on treated skin of rabbit No 1. Rabbit No 2 showed no pathological changes.
During observation after 7 days no pathological changes on treated skin of rabbit No 1 were stated.
Other effects:
At the start of the experiment rabbit No 1 weighed 4.02 kg, rabbit No 2 - 2.99 kg while rabbit No 3 - 3.11 kg. At the end of the experiment body weight of rabbits amounted: rabbit No 1 – 4.1 kg, rabbit No 2 – 3.11 kg and rabbit No 3 – 3.27 kg.

Any other information on results incl. tables

Chelate with name: Fe (III) IDHA, Point evaluation of acute skin irritation/corrosion study for rabbits

Rabbit No

Observation type

Evaluation after

Average after 24, 48 and 72 h

1 h

24h

48h

72 h

7 days

1

erythema

1

1

1

1

0

1

oedema

0

0

0

0

0

0

2

erythema

1

1

0

0

-

0.3

oedema

0

0

0

0

-

0

3

erythema

1

0

0

0

-

0

oedema

0

0

0

0

-

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item Fe (III) IDHA does not irritate skin of rabbits.
Executive summary:

Acute skin irritation/corrosion study of Chelate with name: Fe (III) IDHA for rabbits was performed according to OECD Guideline for Testing of Chemicals No 404/Method B.4. as well as Principles of Good Laboratory Practice (GLP - OECD, 1997). The study was performed with white rabbits of New Zealand strain. The tested substance was administered in amount of 0.5 g as a single dose to shaved skin of three rabbits and covered with appropriate band. The exposure time was 4 hours. After 1, 24, 48, 72 hours and 7 days since the end of exposure skin condition was examined. During observations all test rabbits showed changes on skin in form of erythema.

Classification of the test material was performed according to Regulation 1272/2008. Taking into account the obtained results, one may state that Chelate with name: Fe (III) IDHA does not irritate skin of rabbits.