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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo for eye irritation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD Guideline 405 and EU Method B.5 The test material has no batch number and no information on purity nor particle size distribution.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Coated copper flake
IUPAC Name:
Coated copper flake
Details on test material:

Lot/batch number: not available
specification: no information was provided on the specification of the sample used in this study.

purity: not available
stability: not available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
At the start of the study the animals weighed 2.0 to 3.5 kg and were 12 to 16 weeks old.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL (approximately 72 mg).
Duration of treatment / exposure:
the test material was placed into the conjuctival sac of the right eye. The upper and lower lids were held together for ca. 1 second after treatment.
Apparently eyes were not rinsed.
Observation period (in vivo):
Up to 14 days
Number of animals or in vitro replicates:
3 per group (females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72h
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72h
Score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72h
Score:
0.7
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72h
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72h
Score:
1.7
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72h
Score:
1.7
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72h
Score:
0.7
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72h
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72h
Score:
1.7
Reversibility:
fully reversible within: 14 days
Other effects:
Clinical signs: copper-coloured staining of the eyelids and fur around the treated eye was noted in all animals during the study

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information however, not classified Criteria used for interpretation of results: EU
Conclusions:
Good quality study. The test material corresponds to the composition of “ coated copper flakes” . In this study the test material showed a slight potential to induce eye irritation. However, the material does not meet the criteria for classification for eye irritation according to Annex VI of Commission Directive 2001/59/EC
Executive summary:

The test material corresponds to the composition of “coated copper flakes” . In this study the test material showed a slight potential to induce eye irritation. However, the material does not meet the criteria for classification for eye irritation according to Annex VI of Commission Directive 2001/59/EC