Registration Dossier
Registration Dossier
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EC number: 443-520-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-22 - 2002-05-30
- 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 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually housed in suspended metal cages
- Diet: Certified Rabbit Diet supplied by PMI Nutrition International, Nottingham UK ad libitum
- 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
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5g (moistened with 0.5 ml of distilled water) - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours (for rabbit 1)
4 hours (for rabbits 2 and 3) - Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
OBSERVATION TIME POINTS
3 minutes, 1 hour and 4 hours (for rabbit 1)
4 hours (for rabbits 2 and 3)
For all, 24, 48, 72h
SCORING SYSTEM:
Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study at all time points.
Primary Irritation Index 0/6, 0.0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a primary irritation index of 0.0 and is not irritant to rabbit skin.
- Executive summary:
The test material produced a primary irritation index of 0.0 and is not irritant to rabbit skin.
The test material did not meet the criteria for classification as irritant or corrosive.
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