Disodium 2-hydroxyethyliminodi(acetate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, acceptable for assessment; limited information on test substance; observation period only 7 days

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

scoring method according to Draize et al., 1944

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium nitrilotriacetate

EC Number:

225-768-6

EC Name:

Trisodium nitrilotriacetate

Cas Number:

5064-31-3

Molecular formula:

C6H9NO6.3Na

IUPAC Name:

trisodium 2,2',2''-nitrilotriacetate

Details on test material:

- Name of test material (as cited in study report): Trisodium Nitrilotriacetate (NTA)
- Physical state: finely ground
- Other: no details reported

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

33.6

Max. score:

37

Remarks on result:

other: considerable discomfort immediately upon application

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

27.6

Max. score:

30

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 h

Score:

20.6

Max. score:

24

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 3d

Score:

14

Max. score:

19

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 5 d

Score:

8.3

Max. score:

11

Results 6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 d

Score:

4.6

Max. score:

8

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: leaving mild redness and slight corneal dullness

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Trisodium nitrilotriacetate (NTA) was classified as a moderate eye irritant in male and female rabbits. The average maximum score was 33.6 out of a possible 110 one hour after application.

Executive summary:

In a primary eye irritation study 100 mg of finely ground Trisodium nitrilotriacetate (NTA) was instilled into the conjunctival sac of right eye of albino rabbits (0-1/sex) for 24 hours. Eyes were rinsed with isotonic saline solution after 24 hours. Animals then were observed for several days. Irritation was scored by the method of Draize et.al., 1944.

Considerable discomfort was shown immediately upon application. Copious discharge, edema with partial eversion of the lids, moderate redness, and sufficient congestion to mildly obsure iris details was recorded after one hour. Discharge reduced in 24 hours as well as edema. Both had disappeared within 5 days, leaving mild redness and slight corneal dullness.

Trisodium nitrilotriacetate (NTA) was classed by expert judgement as a moderate eye irritant in male and female rabbits. The average maximum score was 33.6 out of a possible 110 after one hour.