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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 60 min
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 day
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
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
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.