Registration Dossier
Registration Dossier
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EC number: 430-380-7 | CAS number: 445409-27-8
Eye irritation
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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Molyvan 855 (OD-855)
- IUPAC Name:
- Molyvan 855 (OD-855)
- Reference substance name:
- -
- EC Number:
- 430-380-7
- EC Name:
- -
- Cas Number:
- 445409-27-8
- Molecular formula:
- Cannot be assigned due to being a complex reaction mixture
- IUPAC Name:
- Amides, coco, N, N-bis(hydroxyethyl), reaction products with coco monoglycerides and molybdenum oxide
- Details on test material:
- - Name of test material (as cited in study report):
OD-856 Organomolybdenum mixture
Constituent 1
Constituent 2
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.
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