Bis(5-oxo-L-prolinato-N1,O2)copper

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No reading at 48h

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Method according to the official journal of French Republic (Offical Journal of 21 february 1982)

Deviations:

yes

Remarks:

deviations from current guideline (no reading at 48h)

Principles of method if other than guideline:

This method is used to evaluate the index of Primary Irritation induced by a test article, after a single application
Any substance provoking after a single applciation an orthoergic inflammatory cutaneous reaction appearing within 24 hours on the application site is designated as a Primary irritant.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(5-oxo-L-prolinato-N1,O2)copper

EC Number:

239-471-4

EC Name:

Bis(5-oxo-L-prolinato-N1,O2)copper

Cas Number:

15454-74-7

Molecular formula:

C10H12CuN2O6

IUPAC Name:

bis(5-oxo-L-prolinato-N1,O2)copper

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: "Elevage scientifiques des dombes, C.E.G.A.V"
- Age at study initiation: Not specified
- Weight at study initiation: 2.3 to 3 kg
- Housing: 1 animal by cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 1 week before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): 3 000 m3/hr
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:

other: gauze + bandage

Preparation of test site:

other: one flank shaved and abraded and the other flank only shaved

Vehicle:

water

Remarks:

distilled

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of product

Duration of treatment / exposure:

24 hours

Observation period:

at 24 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 3x3 cm square patchs
- Type of wrap if used: Adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS: at 24 hours and 72 hours
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: primary dermal irritation index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all 6

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: no reading at 48h

Results 2

Irritation parameter:

edema score

Basis:

animal: all 6

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: no reading at 48h

Irritant / corrosive response data:

NB: no reading at 48h

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, test item is not classified according to CLP regulation and GHS

Executive summary:

According to non-GLP study following a national protocol, slightly irritation is observed, however CLP or GHS classification is not warranted.