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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dicopper hydroxide phosphate
EC Number:
235-285-2
EC Name:
Dicopper hydroxide phosphate
Cas Number:
12158-74-6
Molecular formula:
Cu2HO5P
IUPAC Name:
dicopper hydroxide phosphate
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

Test animals / tissue source

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.

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.