pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on batch number and identity. Basic data given: comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Remarks:

but Quality Statement included

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-290-3

EC Name:

-

Cas Number:

7216-95-7

Molecular formula:

C14H18K5N3O10

IUPAC Name:

pentapotassium 2-[bis({2-[bis(carboxylatomethyl)amino]ethyl})amino]acetate

Details on test material:

No data on composition and batch number.
Appearance: solid
Date of receipt: 5 January 1987
Stored at ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Frosfield Rabbits, Petersfield, UK
- Age at study initiation: ca. 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but duration not indicated


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


IN-LIFE DATES: From: 19 January To: 2 February 1987

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 70 mg (this weight occupying a volume of 0.1 ml)

Duration of treatment / exposure:

single application; eyelids gently held together for 1 second before releasing

Observation period (in vivo):

Up to 14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated


SCORING SYSTEM:

CORNEA

Degree of density (most dense area used)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre) 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacrous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*

IRIS

Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection,
any or all of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*

CONJUNCTIVAE

Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected)l 1
Diffuse, crimson colour, indiviual vessels not easily discernible 2*
Diffuse, beefy red 3*

Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half closed 3*
Swelling with lids more than half closed 4*

[Note: * interpreted as a positive effect.]


TOOL USED TO ASSESS SCORE: hand-held torch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days (2 animals), 14 days (1 animal)

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable as no effects were present

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days (2 animals), within 14 days (1 animal)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days (2 animals), 14 days (1 animal)

Irritant / corrosive response data:

The test material elicited a positive response in all of the 3 treated animals:
- temporary corneal opacities developed in 2 animals,
- a diffuse, crimson red colouration of the conjunctivae was observed accompanied by swelling with partial eversion of the lids in
all 3 animals,
- iridial inflammation was not seen in any of the animals

Other effects:

No other effects were reported.

Any other information on results incl. tables

Summary for scoring of ocular lesions

Animal no.	Effect	Hour	Days after instillation						Result (+/-)
		1*	1	2	3	4	7	14
1506	Cornea Iris Redness Chemosis	0 0 2 2	0 0 2 2	2 0 1 2	2 0 1 1	2 0 2 1	1 0 1 1	0 0 0 0	+
1507	Cornea Iris Redness Chemosis	0 0 2 2	1 0 2 2	2 0 1 1	2 0 1 1	0 0 1 0	0 0 0 0		+
1508	Cornea Iris Redness Chemosis	0 0 2 2	0 0 2 1	0 0 1 1	0 0 1 1	0 0 1 0	0 0 0 0		+

+ = positive result; - = negative result

Mean score cornea 24/48/72 hours: 1.33 / 1.67 / 0 for the 3 animals, respectively

Mean score iris 24/48/72 hours: 0 for all 3 animals

Mean score redness 24/48/72 hours: 1.33 for all 3 animals

Mean score chemosis 24/48/72 hours: 1.67 / 1.33 / 1.0 for the 3 animals, respectively

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Instillation of the test material into the rabbit eye elicited a borderline positive response (mean cornea score of 1.00 in the three animals, and 2 out of 3 animals a score above 1.0) according to OECD-GHS criteria, as such this substance should be labeled in Category 2A (reversible in 21 days).

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used

followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" and Method B5 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single application of the test material to the eye of three rabbits produced corneal opacity, redness and chemosis (all at a maximum score of 2) but no iridial inflammation. All treated eyes appeared normal within 7 days (2 animals) or 14 days (1 animal) after treatment.

The test material was classified as an irritant (Category 2, subcategory 2A) to the rabbit eye according to OECD-GHS.