Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.3.-10.4.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
>= 0 - <= 3
Max. score:
3
Reversibility:
fully reversible

Any other information on results incl. tables

5-nitroisophthalic acid
animal   1 h 24 h 48 h 72 h
1 cornea 2 2 2 1
  iris 0 0 0 1
  conjunctivae 1 1 1 1
  chemosis 3 1 0 0
2 cornea 2 2 1 1
  iris 0 0 0 0
  conjunctivae 1 1 1 1
  chemosis 1 0 0 0
3 cornea 2 1 0 0
  iris 0 0 0 0
  conjunctivae 1 1 1 1
  chemosis 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU