Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)

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:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Black red, fine grained and free-flowing solid

Details on test material:

- Analytical purity: 100 % (UVCB)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No details available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

- Amount applied: 0.5 g test article moistened with 0.18 g of purified water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours after removal of the bandage as well as day 7 and 14

Number of animals:

3

Details on study design:

No details available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The observed skin reactions were fully reversible within 14 days.

Other effects:

No other effects were observed.

Any other information on results incl. tables

Table: Individual scores.

	time	animal 1	animal 2	animal 3
erythema	1 h	2	2	2
	24 h	2	2	2
	48 h	1	1	1
	72 h	1	1	1
	7 d	0	1	1
	14 d	0	0	0
edema	1 h	1	0	1
	24 h	0	1	1
	48 h	0	0	0
	72 h	0	0	0
	7 d	0	0	0
	14 d	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Application of this test article to the rabbit skin can be designated as not irritating.

Executive summary:

Skin irritation potential of FeNaEDDHA was evaluated in a skin irritation study according to the OECD guideline 404. 3 New Zealand White rabbits were exposed dermally to the test article for 4 hours under semiocclusive condition. The skin reactions were examined 1, 24, 48 and 72 hours after removal of bandage as well as on day 7 and 14. Erythema and oedema observed in treated animals were fully reversible within 14 days.

The test material can be considered as not irritating to skin since the mean scores in treated animals are all below the trigger values defined in the EU CLP (Regulation (EC) No. 1272/2008) for classification as skin irritant.