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EC number: 283-044-5 | CAS number: 84539-55-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-09-29 to 1993-11-09
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- EC Number:
- 283-044-5
- EC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- Cas Number:
- 84539-55-9
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- Details on test material:
- - Test article: CGA65047 SG 100, (A-5787 A), identical to FeNaEDDHA
- Additional specification: Sesquestrene 138 Fe 100 SG
- Physical state: granules; miscible in water
- Analytical purity: 100% (UVCB)
- Lot/batch No.: P.201845
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 241 to 2570
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit pellet-Nafag No.814
- Water (e.g. ad libitum): ad libitum, fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and sevred as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied):80 mg (quantity corresponding to a volume of 0.1 ml) - 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 (female)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Individual eye scores
|
||||
|
CORNEA |
IRIS |
CONJUNCTIVA |
|
|
|
|
redness |
chemosis |
animal No. 772/F |
ce/te |
ce/te |
ce/te |
ce/te |
after 1 hr. |
0/1 |
0/0 |
0/1 |
0/1 |
after24 hrs. |
0/0 |
0/0 |
0/2 |
0/0 |
after48 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
after 72 hrs. |
0/0 |
0/0 |
0/0 |
0/0 |
mean 24-72 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
after 7 days |
0/0 |
0/0 |
0/0 |
0/0 |
|
|
|
|
|
|
CORNEA |
IRIS |
CONJUNCTIVA |
|
|
|
|
redness |
chemosis |
animal No. 084/F |
ce/te |
ce/te |
ce/te |
ce/te |
after 1 hr. |
0/1 |
0/1 |
0/1 |
0/1 |
after 24 hrs. |
0/0 |
0/1 |
0/2 |
0/1 |
after 48 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
after 72 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
mean 24-72 hrs. |
0/0 |
0/0.33 |
0/1.33 |
0/0.33 |
after 7 days |
0/0 |
0/0 |
0/0 |
0/0 |
|
|
|
|
|
|
CORNEA |
IRIS |
CONJUNCTIVA |
|
|
|
|
redness |
chemosis |
animal No. 108/F |
ce/te |
ce/te |
ce/te |
ce/te |
after 1 hr. |
0/1 |
0/1 |
0/1 |
0/1 |
after 24 hrs. |
0/1 |
0/1 |
0/2 |
0/1 |
after 48 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
after 72 hrs. |
0/0 |
0/0 |
0/1 |
0/0 |
mean 24-72 hrs. |
0/0.33 |
0/0.33 |
0/1.33 |
0/0.33 |
after 7 days |
0/0 |
0/0 |
0/0 |
0/0 |
ce = control eye
te = test eye
F = female
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 FeNaEDDHA to the rabbit eye can be designated as not irritating.
- Executive summary:
An acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FeNaEDDHA in the albino rabbit eye and the associated mucous membranes. The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and the EU method B.5 (Acute Toxicity: Eye Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal eye conditons. 0.1 mL (80 mg) of the test item was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test article. The animals were checked daily for systemic symptoms and mortality. Because reactions were observed within 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. According to the GHS Regulation (EC) No. 1272/2008 the test article FeNaEDDHA can be classified as non-irritant to albino rabbit's eye. The eye reactions observed were reversible until the end of the observation period on day 7.
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