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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from March 12, 2001 to April 03, 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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

hygiene: optimal hygienic conditions
room temperature: average of 20.3°C (continuous control and recording)
relative humidity: average of 51.6% (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

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

74 mg - approximated equivalent of 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours p.a.

Number of animals or in vitro replicates:

1 female

Details on study design:

Additional eye examinations were performed 6, 8 10, 13 15 & 21 days after the instillation.
A further examination by instillation of a fluorescein solution (Minims Fluorescein Sodium 2%) onto the cornea was performed 48 hours p.a.
The whole eye, especially the cornea, the iris and the conjunctivae were examined, using a otoscope lamp.
In addition to the eye examinations, the animals were observed for other than local changes at all observation times too.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean (24-72h)

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: irreversible corneal alterations

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean (24-72h)

Score:

1

Max. score:

1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean (24-72h)

Score:

2.7

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean (24-72h)

Score:

2.3

Max. score:

4

Other effects:

No other than ocular alterations were noted.

Any other information on results incl. tables

Cornea: Irreversible corneal alterations with scores of "2" were observed from 24 h to 72 h p.a. ; 6 d p.a. the score increased to "3". The affected area was one half to the whole cornea. Additionally a corneal neovascularisation, arising from the sclera was seen from 8 d to 21 d p.a. 75% of the cornea were homogeneously stained after an additional examintaion by instillation of fluorescein. This indicates a damage of the anterior corneal epithelium.

Iris: A sluggish reaction to the light (score "1") was noted from 24 h p.a. until 72 h p.a. From 6 d until 8 d p.a. no examinations were possible due to the corneal alterations. From 10 d until 21 d.p.a., the iris was normal.

Conjunctivae, redness: The animal was affected with scores ranging from "3" to "1", from 1 h p.a. onwards until a maximum of 10 d p.a.

Conjunctivae, chemosis: Swelling was noted from 1 h onwards until a maximum of 72 h p.a., starting with scores of "4" and afterwards decreasing.

Applicant's summary and conclusion

Interpretation of results:

other: risk of serious damage to eyes.

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test substance Copper Hydroxide Nitrate causes irreversible ocular lesions.
According to these results and to the EU CLP Regulation (n° 2008/1272), the test substance Copper Hydroxide Nitrate poses a "risk of serious damage to eyes".