Copper hydroxide nitrate (Cu2(OH)3(NO3))

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from March 12, 2001 to March 16, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

439-590-3

EC Name:

-

Cas Number:

12158-75-7

Molecular formula:

Cu2H3NO6

IUPAC Name:

copper(2+) hydroxide nitrate

Details on test material:

batch n°: 060248
composition of the test material: Cu=52.6% - N=5.4% - H=1.5% - O=36.8%
solubility in water: practically insoluble
expiration date of the batch: February 2002
storage conditions of test substance: ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

hygiene: optimal hygienic conditions
room temperature: average of 20.3°C (continuous control and recording)
relative humidity: average of 50.8% (continuous control and recording)
air exchange: 12 per hour
light: artificial light from 6 a.m. to 6 p.m.
cages: individual caging in metal wire cages, type KK016R, with a wooden rest shelf
feed: Altromin 2023 diet for rabbits, ad libitum (producer: Altromin GmbH, D-32761 Lage) ; random samples of the feed are analysed for contaminants by Altromin ; Hay-briquettes (supplied by SSNIFF, D-59494 Soest) were offered additionally as a dietary supplement
water: tap water from an automatic watering system, ad libitum
identification: labelling with felt-tipped pen in a pinna
acclimatisation: 5 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: hair was clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal

Number of animals:

3 females

Details on study design:

Test substance administration:
Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. the test sites were median on the dorsal thoracal region.
Samples with approximately 0.5 g of the test substance were moistened with 1 mL deionised water and were placed on cellulose patches in a size of about 2.5 cm * 2.5 cm and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes. The application sies were covered semi-occlusively by a dressing.
Access by the animals to the application sites was prevented by a plastic collar.
At the end of the exposure period, the dressings, the tapes with the patches and the collars were removed, residual test substance was wiped off with wet Kleenex-tissues, if necessary.
Skin examinations:
The skins of the animals were examined for local alterations after the clipping procedure, one day before the application and immediately before application. the treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.
No further examinations were performed thereafter.
The skin was examined using a cold light source KL1500 electronic.
General examinations:
The animals were examined once daily for other than local changes of the skin.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: erythema/eschar score

Basis:

mean

Time point:

other: mean (24-72h)

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean (24-72h)

Score:

0

Max. score:

0

Other effects:

No general toxic effects were noted.

Any other information on results incl. tables

A light-blue staining of the skin at the application site was seen in all animals from 1h p.a. until a maximum of 24h after patch removal, but did not impede the xamination of the skin for erythema. The discoloration is directly attributed to a staining property of the test substance and not considered to be a toxic effect. Except for this, all exposed skin sites were normal at each examination term.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance Copper Hydroxide Nitrate is not irritating to the skin as per EU Regulations.