Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 20 September 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate

EC Number:

700-903-6

Cas Number:

255830-15-0

Molecular formula:

C3H7K5NO10P3

IUPAC Name:

pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate

Constituent 2

Reference substance name:

ATMP-N-oxide-5K

IUPAC Name:

ATMP-N-oxide-5K

Details on test material:

- Name of test material (as cited in study report): SPE9402 (Phosphonic acid aqueous formulation)

- Physical state: clear colourless liquid

- Storage condition of test material: room temperature

-Other: Reviewers' note: the substance was identified in the study report as the acid form (CAS 15834-10-3), but it is clear that the form of substance to which animals were exposed would have been the potassium salt at pH 11.3.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Regal Group UK Ltd., Great Bookham, Surrey England
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 3-3.6 kg
- Housing: individually in metal cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

Examination of the eyes was made after 1 hour and 1, 2, 3 days after instillation (24, 48 and 72 hours). Additional observation was made for main study animals four days after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: numerical scoring system similar to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Remarks on result:

probability of weak irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Remarks on result:

probability of weak irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Remarks on result:

probability of weak irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Remarks on result:

probability of weak irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Remarks on result:

probability of weak irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

There were no signs of toxicity or ill health in any rabbit during the observation period. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels to a diffuse crimson colouration of the conjunctivae with slight swelling was observed, resolving in all instances four days after instillation.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
60 min	0/0/0	0/0/0	2/1/1	1/1/1
24 h	0/0/0	0/0/0	2/2/1	1/2/1
48 h	0/0/0	0/0/0	1/2/1	1/1/0
72 h	0/0/0	0/0/0	1/1/1	0/0/0
Average 24h, 48h, 72h	0	0	1.3	0.7

 

 

Instillation of the test material into the rabbit eye elicited transient, very slight to well defined conjunctival irritation only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study, conducted in a similar manner to OECD TG 405 and in compliance with GLP, ATMP-N-oxide was found mildly irritating to the eyes of rabbit.