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

Eye irritation

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Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No details are available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

- Amount applied: 69 mg (quantity corresponding to a volume of 0,1 mL)

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

1, 24, 48, 72 hours; to reveal a possible reversibility, readings were continued on Day 7.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

0.6

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.55

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24+48+72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

No further data available

Other effects:

No other effects were noted

Any other information on results incl. tables

	time	animal 1	animal 2	animal 3
corneal opacity	24 h	2	0	0
	48 h	0	0	0
	72 h	0	0	0
iris	24 h	1	1	1
	48 h	1	0	0
	72 h	1	0	0
conjunctivae	24 h	1	1	1
	48 h	0	0	0
	72 h	0	0	0
chemosis	24 h	1	1	1
	48 h	0	0	0
	72 h	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 the test article to the rabbit's eye can be designated as not irritant.

Executive summary:

Eye irritation potential of FeNaEDDHA was evaluated in an eye irritation study according to the OECD guideline 405. The test material (0.1 mL) was applied into the conjunctival sac of the left eye in 3 New Zealand White rabbits. The animals were checked daily for systemic signs of toxicity and mortality. The reactions were fully reversible within 14 days.

The test material can be considered as not irritating to eyes 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 eye irritant.