Reaction mass of iron chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid and sodium chloride

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fe(III)IDHA

IUPAC Name:

Fe(III)IDHA

Constituent 2

Reference substance name:

666828-40-6

Cas Number:

666828-40-6

IUPAC Name:

666828-40-6

Test material form:

other: microgranules

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 6

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.