Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)

Endpoint summary

Description of key information

Two studies were available on skin irritation, one using a 80% solution, the other study using a 50% solution. The 80% solution showed slight skin irritation but not sufficient for classification, the 50% solution did not show skin irritation. Two studies were also available for eye irritation. The key study showed irritation just sufficient to require classification, the supporting study showed slight irritation not sufficient for classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study lacks some details; in this study an 80% solution was tested

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

Principles of method if other than guideline:

Skin irritation was evaluated following application of a 80% aqueous solution

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No details available.

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

No info

Duration of treatment / exposure:

The backs of the animals were treated for 1, 5, 15 min or20 h.
The ears of the animals were treated for 20 h.

Observation period:

8 days

Number of animals:

not indicated

Irritation parameter:

overall irritation score

Remarks on result:

other: see below

Irritant / corrosive response data:

Effects on the back after 24 h: no abnormalities observed following exposure for 1, 5 or 15 min. Slight red staining observed following 20 h of exposure.
Effects on the back after 8 days: no abnormalities observed.

Effects on the ear after 24 h: slight redness observed following exposure for 20 h
Effects on the ear after 8 days: no abnormalities observed

Interpretation of results:

GHS criteria not met

Conclusions:

Although slight irritation (redness) was observed, no classification and labeling was considered to be needed based on the results of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Relatively well reported study, no GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: two males (2.62 and 2.73 kg), one female (2.96 kg)
- Housing: 1 per cage (stainless steel)
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.1 ml bulk volume was applied (ca. 61 mg of the comminuted test substance)

Duration of treatment / exposure:

Single application

Observation period (in vivo):

Up to 8 days; scoring at 1, 24, 48, and 72 h and 8 days after application

Number of animals or in vitro replicates:

3 (2 males, 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: according to 83/467/EEC

TOOL USED TO ASSESS SCORE: no info

Irritation parameter:

cornea opacity score

Basis:

animal: 1,2,3

Time point:

24/48/72 h

Score:

0.89

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal: 1,2,3

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal: 1,2,3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: 1,2,3

Time point:

24/48/72 h

Score:

0.89

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See table below

Other effects:

No info

Summary of ocular lesions

 

Anim. No.	Effect	Hours	Days after application					Mean score cornea Days 1/2/3	Mean score iritis Days 1/2/3	Mean score redness Days 1/2/3	Mean score chemosis Days 1/2/3
		1	1	2	3	8
1 (M)	Cornea Iris Redness Chemosis	0 0 2 2	1 0 2 1	1 0 2 0 PC	1 0 1 0	0 0 0 0		1.00	0	1.67	0.33
2 (F)	Cornea Iris Redness Chemosis	0 0 2 2	1 0 2 2	1 0 1 1	0 0 1 0	0 0 0 0		0.67	0	1.33	1.00
3 (M)	Cornea Iris Redness Chemosis	0 0 2 2 PC	1 0 2 2 PC/S	1 1 2 1 PC/S/DC	1 1 2 1 PC	1 0 1 0		1.00	0.67	2.00	1.33
Mean all anim.								0.89	0.22	1.67	0.89

PC = pupil contracted, DC= detachment of the cornea, S = suppuration

Interpretation of results:

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

Conclusions:

Because two animals out of three showed corneal opacity >= 1 calculated as the mean score following grading at 24, 48 and 72 h after instillation and is expected to be fully reversible within an observation period of 21 days, the test material needs to be classified as eye irritant Cat. 2 (2A).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Most metal chelates are not irritating to the skin (see read across document in section 13). Most metal chelates are neither irritating to the eyes, but in this case EDTA-CuNa2 was borderline irritating to the eyes.

Justification for classification or non-classification

Based on the results of two skin irritation studies it was concluded that no classification was needed for this endpoint. For the endpoint eye irritation classification with GHS Cat. 2 (2A) should be applied based on the borderline eye irritation observed.