Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 November 2009 - 04 December 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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
Details on test material:
- Name of test material (as cited in study report): OS238132
- Physical state: tan colored solid
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Not required; left eye used as untreated control
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
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: 24, 48, and 72 hour average
Score:
0
Max. score:
4
Reversibility:
other: no effects noted on cornea at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hour average
Score:
0
Max. score:
2
Reversibility:
other: No effects noted on iris at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hour average
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hour average
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 12.0 and was classified as a MILD IRRITANT (Class 4 on a I to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. This mateiral is not classifiable as an eye irritant uner the EU DSD or CLP criteria.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit according to OECD Guideline No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002) and Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 20041731EC. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 72-hour observation. The Group Mean Scores according to the Draize scale were 12.0, 10.7, 5.3 and 0.0 out of 110 at 1, 24, 48 and 72 hours respectively. The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. This mateiral is not classifiable as an eye irritant uner the EU DSD or CLP criteria.