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Administrative data

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: Very limited reported study, in this study an 80% solution was tested.
Reason / purpose:
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 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:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
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:
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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 selection of skin irritation / corrosion endpoint:

Two studies available, one using 80% the other study using a 50% solution.

Justification for selection of eye irritation endpoint:

Relatively well performed and reported study.

Effects on eye irritation: irritating

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.