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Diss Factsheets

Administrative data

Description of key information

The test material (dicopper hydroxide phosphate) did not cause skin or eye irritation.

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:
The test was conducted between 25 November 2010 and 28 November 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): dicopper hydroxide phosphate
-CAS Number: 12158-74-6
- EC Number: 235-285-2
- Purity test date: 15/01/2009
- Lot/batch No.: 08004
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data (young adults)
- Weight at study initiation: <2 kg

The animals were acclimated and permanently controlled by veterinarians according to DIN EN ISO 10993-2. They were immunised against myxomatosis and RHD.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of test material moistened with a small amount of water.

Duration of treatment / exposure:
4 hours
Observation period:
72 hours (as no effects were noted it was not necessary to observe the animals for any longer).
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: The fur on the back of three rabbits was closely clipped on both sides of the spinal column (10 x 10 cm).
- Type of wrap if used: 4-ply gauze patches (25 x 25 mm). The gauze patches were covered with a non-occlusive gauze patch and wrapped with an occlusive bandage for 4 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the contact time (4 hours) the dressings were removed and residual substance was washed off with warm water. The skin was blown dry.


SCORING SYSTEM:
see table 1 below.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
No loss of bodyweight or other adverse systemic effects were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material (dicopper hydroxide phosphate) did not cause skin irritation.
Executive summary:

The test material (dicopper hydroxide phosphate) did not cause skin irritation and as such is not considered to be classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
animals were only observed for 72 hours post-instillation. This is considerd to be a deficiency, however, the data is sufficient for classification and labelling.
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): dicopper hydroxide phosphate
-CAS Number: 12158-74-6
- EC Number: 235-285-2
- Purity test date: 15/01/2009
- Lot/batch No.: 08004
- solid: particulate/powder
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data (young adults)
- Weight at study initiation: <2 kg

The animals were acclimated and permanently controlled by veterinarians according to DIN EN ISO 10993-2. They were immunised against myxomatosis and RHD.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test material was ground to a fine powder. A mass of 100 mg of moistened test material was placed in the lower conjunctival sacs of the right eyes of the test animals.
Duration of treatment / exposure:
Following instillation the eyelids were kept shut for 1 second.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not done


SCORING SYSTEM: Draize scale as indicated in the test guideline.

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Observations were only carried out up to 72 hours, reversibility within 21 days is expected
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Observations were only carried out up to 72 hours, reversibility within 21 days is expected
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Animal 2 showed diffuse crimson colour of conjunctivae and individual vessels were not easily discernible after 1 hour and 24 hours of treatment. In addition some swelling of the lid / nictating membrane above normal was observed as well as increased secretion. After 48 h and 72 h of treatment animal 2 showed some hyperaemic blood vessels regarding conjunctivae and an increased secretion. After 48 h of treatment animal 3 showed diffuse crimson colour of conjunctivae and individual vessels were not easily discernible.
Interpretation of results:
GHS criteria not met
Conclusions:
Dicopper hydroxide phosphate is not considered to be classified as irritating to the eyes.
Executive summary:

In accordance with Regulation EC No. 1272/2008 (EU CLP) dicopper hydroxide phosphate is not considered to be classified as irritating to the eyes. Despite the deficiencies identified in the above summary, this study is considered to be adequate and reliable for use as a key study (in accordance with Regulation (EC) No. 1907/2006) and for classification and labelling.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In accordance with Regulation EC No. 1272/2008 (EU CLP) dicopper hydroxide phosphate is not considered to be classified as irritating to the skin or the eyes.