Pentasodium pentahydrogen [[(phosphonatomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.05.2000 to 15.05.2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt

EC Number:

244-751-4

EC Name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt

Cas Number:

22042-96-2

IUPAC Name:

sodium hydrogen [10,10-dihydroxy-10-oxido-2,5,8-tris(phosphonomethyl)-2,5,8-triaza-10-phosphadec-1-yl]phosphonate

Constituent 2

Reference substance name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt

IUPAC Name:

[[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphos phonic acid, sodium salt

Details on test material:

- Name of test material (as cited in study report): Dequest 2066A
- Substance type: Phosphonate
- Physical state: Clear amber liquid
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature
No further details available.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: Individually in suspended stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 46-82
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 12.05.2000 to 15.05.2000

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Six

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: EEC Ocular Evaluation Criteria

TOOL USED TO ASSESS SCORE: auxiliary light source, fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hour

Score:

4.11

Reversibility:

fully reversible

Remarks on result:

other: considered non-irritating

Irritant / corrosive response data:

Exposure to the test substance produced corneal opacity in 4/6 test eyes at the 1-hour scoring interval. The corneal opacity resolved in all test eyes by the 24hour scoring interval. Iritis was observed in 6/6 test eyes at the 1-hour scoring interval and resolved completely in all test eyes by the 48-hour scoring interval. Conjunctivitis (redness, swelling and/or discharge) was noted in 6/6 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by the 72-hour scoring interval. Additional ocular findings included slight dulling of the normal luster of the cornea which was noted in 2/6 test eyes.
A mechanical abrasion was observed in 1/6 control eyes during the fluorescein examination, but was not considered to be significant due to its transient nature. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Other effects:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

In an eye irritation study conducted to OECD 405 and GLP (reliability score 1) Dequest 2066A (sodium salt of DTPMP) was not irritating to the eyes of rabbits.