Registration Dossier

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:
other: conducted to OECD/EC guidelines with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Belcor 575 trisodium salt
- Physical state: Aqueous solution
- Aqueous sodium salt solution formed by neutralising acid with sodium hydroxide (52% Belcor 575, 48% NaOH)
- Lot/batch No.: PAD-A-240-226-D
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2310 - 2880 grams
- Housing: 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 C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
Test material was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control.
Observation period (in vivo):
1, 24, 48, 72 hours.
Number of animals or in vitro replicates:
3 male rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: not irritating
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: not irritating
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
2.22
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: not irritating
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72h
Score:
0.45
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: not irritating

Any other information on results incl. tables

The occular reactions were evaluated according to the OECD scoring system 1, 24, 48 and 72 hours after instillation of the test material. The test material induced irritation of the conjunctiva within 72 hours after instillation. The observation period was therefore extended to 7 days to determine the reversibility of the reactions. Because the mean values of the scores 24 to 72 hours after instillation are below the threshold of significance, the test material can be classed as non irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Trisodium [carboxy(oxido)methyl]phosphonate is not irritating to the eye.
Executive summary:

In a primary eye irritation study 0.1 mL of Trisodium [carboxy(oxido)methyl]phosphonate was instilled into the conjunctival sac of three 9 -13 week old male New Zealand white rabbits for 72 hours.  Animals then were observed for 7 days. 

 In this study, trisodium [carboxy(oxido)methyl]phosphonate is not an eye irritant