Registration Dossier
Registration Dossier
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EC number: 443-520-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-06-13 - 2002-07-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2000-04-26
Test material
- Reference substance name:
- -
- EC Number:
- 443-520-7
- EC Name:
- -
- Cas Number:
- 33016-77-2
- Molecular formula:
- C2H4Na4O6P2
- IUPAC Name:
- tetrasodium (1-phosphonatoethenyl)phosphonate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark
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: 12-20 weeks old
- Weight at study initiation: 2.0 - 3.53 kg
- Housing: Individually housed in suspended metal cages
- Diet: Certified Rabbit Diet supplied by PMI Nutrition International, Nottingham, UK and IPS Product Supplies Limited, Northants, UK
- Water: ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml (79 mg)
(Initially a single rabbit was treated. After consideration of the response of the first animal, two additional animals were treated and in order to minimise pain on application one drop of local anaesthetic was installed 1 to 2 minutes before treatment.) - Duration of treatment / exposure:
- No washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment. Scattered or diffuse corneal opacity was used in two treated eyes at the 24-hour observation. Scattered or diffuse corneal opacity persisted in one treated eye at the 48-hour observation with translucent corneal opacity at the 72-hour observation and scattered or diffuse corneal opacity at the 7 and 14-day observations. Vascularisation, localised ingrowth of vessels for 2 mm to 3 mm, was noted in one treated eye at the 7 and 14-day obervations.
Iridial inflammation was noted in one treated eye one hour after treatment and in two treated eyes at the 24 and 48-hour observations and persisted in one treated eye at the 72-hour observation.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24, 48 and 72-hour observations. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation in two treated eyes at the 7-day observation. Minimal conjunctival irritation was noted in one treated eye at the 14-day observation.
Petechial haemorrhage scattered over the nicitating membrane was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations and in two treated eyes at the 72-hour and 7-day observations.
Two treated eyes appeared normal at the 14-day observation and one treated eye appeared normal at the 21-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The test material was irritating to the eyes of rabbits but all effects were reversible within 21 days.
- Executive summary:
According to the Regulation (EC) No 1272/2008, VDPA Tetra Sodium Salt should be classified as Irritating to eyes (Category 2A).
The test material was irritating to the eyes of rabbits but all effects were reversible within 21 days.
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