L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 April to 11 May 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

eyes were not examined at 1 h and eye irritation was scored in accordance with Draize

Principles of method if other than guideline:

The study was designed to assess eye irritation potential using a procedure based on Proctor and Gamble Protocol No. C2B-E (Dated 16 March 1987). This protocol is essentially equivalent to OECD Guideline 405. Occular lesions were scored using the Draize numerical scoring system (Draize JH, 1959).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-530-4

EC Name:

-

Cas Number:

178949-82-1

Molecular formula:

C10H13N2Na3O8

IUPAC Name:

trisodium 2-({2-[(1-carboxy-2-carboxylatoethyl)amino]ethyl}amino)butanedioate

Details on test material:

- Name of test material (as cited in study report): trisodium EDDS (under code)
- Substance type: technical product
- Physical state: white granular powder
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: March 1990
- Storage condition of test material: "ambient"
- Other: test substance was finely ground using a pestle and mortar and then passed through a 425 micron sieve

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Smith A, Warlingham, Surrey and Froxfield Farms UK Ltd, Petersfield, Hampshire, England
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS standard rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: "were acclimated" no further details given

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

IN-LIFE DATES: From: To: 24 April 1989 to 11 May 1989

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mg [this is quite a low amount]

Duration of treatment / exposure:

The treated eyes were not rinsed after instillation

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinse

SCORING SYSTEM: based on the numerical scoring system of Draize (Draize JH, 1959. Appraisal of the safety of chemicals in foods, drugs and cosmetics. Assn. of Food and Drug Officials of the United States, 51). The Maximum Average Score (MAS) was defined as "the highest Primary Irritation Score recorded for any observation period". The Primary Irritation Score at each observation period for each group of animals was calculated by totalling all of the cornea, iris, and conjunctivae scores and dividing by the number of animals in the group.

TOOL USED TO ASSESS SCORE: handheld torch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

110

Reversibility:

other: not applicable

Remarks on result:

other: No occular reactions were recorded at any of the observation time points.

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No corneal damage, iridial inflammation or conjunctival reactions were seen in any of the three animals during the observation period

Other effects:

none reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a GLP study conducted according to a protocol similar to OECD Guideline 405, no evidence of corneal damage, iridial inflammation or conjunctival reactions were observed when 4 mg of trisodium EDDS was instilled into one eye of each of three rabbits.

Executive summary:

In a GLP study conducted according to a protocol similar to OECD Guideline 405, the ability of trisodium EDDS to cause eye irritation and corrosion was investigated by instilling 4 mg of the undiluted material into the conjunctival sac of one eye of each of three New Zealand White rabbits. Treated eyes were not rinsed after substance application. The contralateral eye remained untreated and served as a control. Scoring of occular effects was performed at 1, 2, 3, 4 and 7 days after test substance administration.

No corneal damage, iridial inflammation or conjunctival reactions were seen in any of the three animals throughout the 7-d observation period. Under the conditions of this study, trisodium EDDS would not be classified as capable of producing serious eye damage/eye irritation according to EU CLP regulation.