Registration Dossier

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:
other: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Principles of method if other than guideline:
Principles and Procedures for Evaluating the Toxicity of Household Substances.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
OD-856 Organomolybdenum mixture

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
undiluted 0.1 ml
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
one time administration
Observation period (in vivo):
1, 24, 48 and 72 hours and again at 4 and 7 days
Number of animals or in vitro replicates:
9 total
6 unwashed (test material only)
3 (test material washed 30 seconds after application with luke warm water)
Details on study design:
9 New Zealand White rabbits were administered 0.1 ml of the test substance in one eye of each rabbit. For six rabbits the treated eye remained unwashed and for the remaining 3 rabbits, the eye was washed 30 seconds post exposure with luke warm water. The other eye of each rabbit served as the control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
other: overall
Time point:
other: 72 hours
Score:
45
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
6.7
Remarks on result:
other: + or - 1.6 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hrs
Score:
2.3
Remarks on result:
other: + or - 1.5 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Remarks on result:
other: + or - 0.8 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
4
Remarks on result:
other: + or - 2.0 (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Remarks on result:
other: + or - 2.0 (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (30 second washout)
Irritant / corrosive response data:
The study report/author did not provide the MMTS, this was calculated based upon the results provided within the study report. All effects noted were fully reversible within 72 hours with only minor effect still being documented in one animal at 48 hours post treatment

Any other information on results incl. tables

No observations are noted as being made on days 4 and 7.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: study author
Conclusions:
Molyvan 855 was found to be moderately irritating.