Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study completed to guideline 84/449/EWG,B.5 GLP Compliance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not applicable
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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 38mgs
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
24,48,72 hrs
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Reversibility:
fully reversible within:
Remarks on result:
other: 2 days
Irritant / corrosive response data:
not classified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is non irritant and non corrosive
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully. It appears from information provided that the substance has low irritation.