Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 April 2013 to 13 May 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 g of the test item
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48, 72 hours; 7, 14, 21 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 hour
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 1 day
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1 hour
Score:
14
Max. score:
110
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 hours
Score:
5
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1 hour
Score:
14
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 hours
Score:
7
Max. score:
110
Reversibility:
not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item Yellow 98-2 has to be classified R41 (according 67/548).
The test item Yellow 98-2 has to be classified in category 1 "irreversible effects on the eye", signal word "Danger" and hazard statement H318 "Causes serious eye damage" (according regulation EC 1272/2008).