Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cobaltate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 27 to February 01, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The batch tested is a commercial product

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 2002

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Cobalt diammonium EDTA

IUPAC Name:

Cobalt diammonium EDTA

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy; Breeder: Harlan France S.a.r.l., F-03800 Gannat, France
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 1.74 to 2.01 kilograms
- Housing: grid-bottomed metal cages suspended over trays measuring 45x51x69 cm (during study) or 48x41x63 cm (during acclimatisation)
- Diet (e.g. ad libitum): STANRAB (P) SQC (Special Diets Services, Witham, Essex CM8 3AD, UK) ad libitum throughout the study
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: At least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 25 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of
12/12 hours

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after application of the test item

Number of animals:

3 (1 for the preliminary and two additional animals for the full test)

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage:
- Type of wrap if used: square gauze measuring 2.5x2.5 cm. The square gauze was then placed onto the animal’s skin with the test item in direct contact with the skin. A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately after exposure

OBSERVATION TIME POINTS
Mortality and morbidity : Twice daily
Body weight : Allocation (Day-1), on termination (Day 4)
Observations : At allocation; approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.

SCORING SYSTEM: Erythema and eschar formation Value
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation 4
preventing grading of erythema

Oedema formation Value
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1mm) 3
Severe oedema (raised more than 1 mm and extending 4
beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

Method

The acute dermal irritation of the test item was investigated in the rabbit, according to the OECD guideline 404.

A 0.5 ml aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed approximately 1, 24, 48 and 72 hours after the end of the exposure period.

Observations

No erythema or oedema was apparent following a 4 hour period of exposure to the test item in any animal of the study.

There was no indication of a systemic effect of treatment. Body weight changes were not remarkable.

Conclusions

These results indicate that the test substance has no irritant effect on the skin of the rabbit.