Registration Dossier
Registration Dossier
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EC number: 223-267-7 | CAS number: 3794-83-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.05.1995 to 15.05.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- EC Number:
- 223-267-7
- EC Name:
- Tetrasodium (1-hydroxyethylidene)bisphosphonate
- Cas Number:
- 3794-83-0
- Molecular formula:
- C2H4Na4O7P2
- IUPAC Name:
- tetrasodium (1-hydroxyethane-1,1-diyl)bis(phosphonate)
- Test material form:
- liquid
Constituent 1
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.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.90 to 3.12 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 48-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 11.05.1995 to 15.05.1995
Test system
- Vehicle:
- other: aqueous solution, administered undiluted.
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After consideration of the ocular responses produced in the first animal, two additional animals were tested. These animals received one drop of local anaesthetic to minimise pain.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Score:
- 6.7
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See below
- Other effects:
- None
Any other information on results incl. tables
CORNEA
No scored effects. Total score 0.
IRIS
No scored effects. Total score 0.
CONJUCTIVAL REDNESS
1 hour 1,1,2
24 hours 1,0,1
48, 72 hours 0,0,0
Total score 6.
CONJUNCTIVAL CHEMOSIS
1 hour 1,1,1
24, 48, 72 hours 0,0,0
Total score 3.
CONJUNCTIVAL DISCHARGE
1 hour 1,1,1
24, 48, 72 hours 0,0,0
Total score 3.
Maximum group mean score = 6.7.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study conducted to OECD 405 and to GLP (reliability score 1) sodium salt of HEDP was not irritating to the eyes of rabbits. There wer minimal conjunctival effects at the one hour time interval, but these were not sufficient to trigger classification.
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