N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

August 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on batch no. and composition. Basic data given: comparable to guidelines/standard

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

audited in-house

Test material

Test material information

Constituent 1

Details on test material:

Test material was used as recieved.
No data on composition or batch number.
Appearance: liquid
Date of receipt: 9 July 1984
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: Morton Commercial Rabbits, Stanted, UK and Pemberley Rabbits, Cottenham, UK
- Age at study initiation: ca. 9-13 weeks
- Weight at study initiation: 2.0-2.8 kg
- Housing: individually in metal cahes 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): ca. 19
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 6 To: 13 August 1984

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

Duration of treatment / exposure:

singe application in one eye, gently held together for 1 second before releasing.

Observation period (in vivo):

up to 7 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:

0

Max. score:

4

Reversibility:

other: not applicable as no effects were present

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable as no effects were present

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 3 days

Irritant / corrosive response data:

No corneal damage or iridial inflammation was observed.
Temporal mild conjunctival irritation was seen in all 3 animals; the eyes were normal 3 days after instillation. However, based on the scoring system, this was not considered to be a positive effect (see scoring system indicated above).

Other effects:

No other effects were observed.

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
786	Cornea Iris Redness Chemosis	0 0 1 1	0 0 1 1	0 0 1 0	0 0 0 0	0 0 0 0	0 0 0 0	-
794	Cornea Iris Redness Chemosis	0 0 1 1	0 0 1 1	0 0 1 0	0 0 0 0	0 0 0 0	0 0 0 0	-
853	Cornea Iris Redness Chemosis	0 0 1 1	0 0 1 1	0 0 1 0	0 0 0 0	0 0 0 0	0 0 0 0	-

Changes (redness and chemosis) were limited to the conjunctivae only

+ = positive result; - = negative result

Mean score cornea 24/48/72 h: 0 for all 3 animals

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

Mean score redness 24/48/72 h: 0.67 for all 3 animals

Mean score chemosis 24/48/72 h: 0.33 for all 3 animals

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Instillation of the test material into the rabbit eye did not elicit a positive response in any of the 3 treated animals according to OECD-GHS criteria.

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".

A single application of the test material to the eye of three rabbits produced minimal conjunctival irritation All treated eyes appeared normal 72 hours after treatment. The test material produced in each animal a maximum score of 1 on redness and also 1 on chemosis.

The test material did not meet the criteria for classification as irritant according to OECD-GHS labelling regulations. No symbol and risk

phrase are required.