Registration Dossier
Registration Dossier
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EC number: 432-770-2 | CAS number: 139189-30-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 28 June 1999 and 2 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)).
Test material
- Reference substance name:
- -
- EC Number:
- 432-770-2
- EC Name:
- -
- Cas Number:
- 139189-30-3
- Molecular formula:
- C38 H40 O8 P2
- IUPAC Name:
- 3-{[bis(2,6-dimethylphenoxy)phosphoryl]oxy}phenyl bis(2,6-dimethylphenyl) phosphate
- Reference substance name:
- Tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate
- IUPAC Name:
- Tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate
- Details on test material:
- - Name of test material (as cited in study report): PX-200- Molecular formula (if other than submission substance): same as submission substance- Molecular weight (if other than submission substance): same as submission substance- Smiles notation (if other than submission substance): same as submission substance- InChl (if other than submission substance): same as submission substance- Structural formula attached as image file (if other than submission substance): same as submission substance- Substance type: white powder- Physical state: solid- Analytical purity: not stated- Impurities (identity and concentrations): not stated- Composition of test material, percentage of components: not stated- Isomers composition: not stated- Purity test date: not stated- Lot/batch No.: F10303- Expiration date of the lot/batch: not stated- Radiochemical purity (if radiolabelling): not stated- Specific activity (if radiolabelling): not stated- Locations of the label (if radiolabelling): not stated- Expiration date of radiochemical substance (if radiolabelling): not stated- Stability under test conditions: not stated- Storage condition of test material: room temperature in the dark- Other: not stated
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK- Age at study initiation: twelve to sixteen weeks- Weight at study initiation: 2.64 to 2.74 kg- Housing:suspended metal cages- Diet: ad libitum - Water: ad libitum- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 23°C- Humidity (%): 30 to 70%- Air changes (per hr): approximately fifteen changes per hour- Photoperiod (hrs dark / hrs light): controlled by a time switch to give twelve hours continuous light and twelve hours darknessIN-LIFE DATES: From: Day 1 To: 72 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 ml which was found to weigh approximately 96 mg- Concentration (if solution): not applicableVEHICLE- Amount(s) applied (volume or weight with unit): not applicable- Concentration (if solution): not applicable- Lot/batch no. (if required): not applicable- Purity: not stated in report
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): not conducted- Time after start of exposure: not applicableSCORING SYSTEM: Kay and Calandra classification systemTOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 145 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 96 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- other: 97 Male
- Time point:
- other: Mean of 24, 48 and 72hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 145 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- other: 96 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 97 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 145 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 2 observed at 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 96 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 2 at 1 hr.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 97 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 2 at 1 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: 145 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 2 at 1 hr, residual test material located in eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: 96 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: Score of 1 at 1 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: 97 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: Score of 1 at 1 hr
- Irritant / corrosive response data:
- A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. dulling of the normal lustre of the cornea was also noted in one treated eye. All treated eyes appeared normal at the 48-hour observation.
- Other effects:
- None noted.
Any other information on results incl. tables
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Dulling of the normal lustre of the cornea was also noted in one treated eye. All treated eyes appeared normal at the 28 hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbols and risk phrases are required.
- Executive summary:
The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council directive 67/548/EEC).
The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbols and risk phrases are required.
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