Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

15708-41-05

IUPAC Name:

15708-41-05

Constituent 2

Reference substance name:

FeNaEDTA

IUPAC Name:

FeNaEDTA

Details on test material:

Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT germany
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.2-2.4
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 4. To: 12.July 2007

Test system

Vehicle:

unchanged (no vehicle)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 h, 4-6 days

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: score for other two animals was 0 at all time points

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: up to 7 days

Score:

0

Max. score:

2

Reversibility:

other: no iris effects in all animals at all time points

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 60 min

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 1 day

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1, 24 and 48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72, and 96 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: all time points up to 7 days

Score:

0

Max. score:

4

Reversibility:

other: no chemosis effects in all animals at all time points

Irritant / corrosive response data:

Under the present test conditions a single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity (grad 1) was observed in animal no. three 24 hours to 6 days after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).
Conjunctival redness (grad 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation.
In addition, secretion was observed in all 3 animals 1 hour after instillation.
The irises were not affected by instillation of the test item.
There were no systemic intolerance reactions.

Any other information on results incl. tables

Time after administration	C O R N E A	I R I S	C O N J U N C T I V A E	C H E M O S I S
	Opacity		Redness
	A n i m a l  n o. : 1 / 2 / 3
before dosing	0/0/0	0/0/0	0/0/0	0/0/0
60 minutes	0/0/0	0/0/0	1/1/0	0/0/0
24 hours	0/0/1	0/0/0	0/1/1	0/0/0
48 hours	0/0/1	0/0/0	0/1/1	0/0/0
72 hours	0/0/1	0/0/0	0/0/1	0/0/0
4 days	-/-/1	-/-/0	-/-/1	-/-/0
5 days	-/-/1	-/-/0	-/-/0	-/-/0
6 days	-/-/1	-/-/0	-/-/0	-/-/0
7 days	-/-/0	-/-/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:

Although the test item induced slight irritation, no classification is needed according to OECD-GHS.

Executive summary:

An eye irritation study with three male Himalyan rabbits according to OECD guideline 405 and GLP was performed.

A single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:

Corneal opacity (grade 1) was observed in animal no. three 24 hours to 6 days after instillation.

The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).

Conjunctival redness(grade 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation. In addition, secretion was observed in all 3 animals 1 hour after instillation.

Irises were not affected by instillation of the test item.

There were no systemic intolerance reactions.