Ammonium iron(III) citrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from experimental study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the OECD [C(81) 30 (final)]

Principles of method if other than guideline:

The purpose of the study was to evaluate the acute eye irritation and/or corrosive effects on the eye following the application of the test article.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium iron(III) citrate

EC Number:

214-686-6

EC Name:

Ammonium iron(III) citrate

Cas Number:

1185-57-5

Molecular formula:

C6H8O7.xFe.xH3N

IUPAC Name:

Ammonium iron (III) citrate

Details on test material:

- Name of test material (IUPAC name): 2-Hydroxypropane-1,2,3-tricarboxylate, ammonium iron (3+) salt
- Common name: Ferric ammonium citrate
- Molecular formula: C6H8O7.xFe.xH3N
- Molecular weight: 264.9979 g/mol
- Smiles notation: N.[Fe+3].OC(=O)CC(O)(CC(=O)O)C(=O)O
- InChl: 1S/C6H8O7.Fe.H3N/c7-3(8)1-6(13,5(11)12)2-4(9)10;;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);;1H3/q;+3;
- Substance type: Organic

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Conelli S.n,c., Via Milano. 61 - 28041 ARONA (Novara - Italy) and received on January 7,1998 (shipping slip No. 00001, dated Itinerary 7,1998).
- Age at study initiation: 2 - 3 months old
- Weight at study initiation: 2.5 - 2.8 kg.
- Fasting period before study:Not specified
- Housing: housed in room T05C
- Diet (e.g. ad libitum): The animals were fed a diet coded "2 RB 15 GLP Certificate" produced by the Charles River ltalia's feed licensec Mucedola S.r.l., Seflimo Milanese. ad libitum.
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2
- Humidity (%):50% ± 15
- Air changes (per hr): approximately 20 air changes per hour (filtered on HEPA 99.97%).
- Photoperiod (hrs dark / hrs light): The room was illuminated by artificial lighting with a 12-hour circadian cycle (7 a.m. - 7 p.m.).


IN-LIFE DATES: From: To: March 3 - March 6,1998

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

0.1 ml / animal

Duration of treatment / exposure:

single dose

Observation period (in vivo):

1, 24, 48 and 72 hours after the test article application.

Number of animals or in vitro replicates:

3 males

Details on study design:

Details on study design
TEST SITE
- Area of exposure: the conjunctival sac of the right eye of each animal


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At 24 hours a washout was performed.
- Time after start of exposure: 1, 24, 48 and 72 hours

SCORING SYSTEM: as mentioned in table 1

TOOL USED TO ASSESS SCORE: After the 24-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.

other : Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed. Negative results were obtained at the fluorescein staining performed 24 hours after the test article application .

Other effects:

Neither mortality nor adverse general clinical modifications were seen during the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant when administered to New Zealand White rabbits as a single ocular application.

Executive summary:

An acute ocular irritation study of test chemical was conducted in the male New Zealand White rabbit (3 animals) in accordance with the OECD [C(81) 30 (final)].

Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.

About 0.1 ml of the test article was placed in the conjunctival sac of the right eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3-4 seconds in order to prevent loss of the material. The other eye (the left eye), remaining untreated, served as control. At 24 hours a washout was performed.

Observations were performed at 1, 24, 48 and 72 hours after the test article application. After the 24-hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution. Inspections for mortality and general clinical signs were made once a day.

Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed.

Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant,when administered to New Zealand White rabbits as a single ocular application.