Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals / tissue source

Species:
rabbit
Strain:
other: Weißer Wiener
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight 2.8 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
The substance was applied undiluted
- Amount(s) applied (volume or weight with unit): 100 µl test material
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
24 hours, 48 hours and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein (last observation day)

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
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Minimal redness of the conjunctivae observed in 2/3 animals, reversible after 72 hours. One animal still showed redness on day 3 (the last day of observation), which is expected to be reversible upon longer observation.

Any other information on results incl. tables

Details on results:

Score

Timepoint

Animal 1

Animal 2

Animal 3

 

 

Test substance

Talcum (control)

Test substance

Talcum (control)

Test substance

Talcum (control)

Conjunctiva Score

1 h

1

2

2

2

2

2

24 h

1

1

1

1

1

1

48 h

1

1

1

1

1

0

72 h

0

1

0

0

1

0

Chemosis Score

1 h

1

0

1

0

0

1

24 h

0

0

0

0

0

0

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

Iris Score

1 h

0

0

0

0

0

0

24 h

0

0

0

0

0

0

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

Cornea Score

1 h

0

0

0

0

0

0

24 h

0

0

0

0

0

0

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be not irritating to eyes.