Registration Dossier
Registration Dossier
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EC number: 223-267-7 | CAS number: 3794-83-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.01.1995 and 07.01.1995
- 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.39-2.67 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 oC
- Humidity (%): 49%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 04.01.1995 and 07.01.1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqueous solution, administered undiluted.
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Back
- % coverage: No data
- Type of wrap if used: patch held in place with a strip of surgical tape, then wrapped in elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was gently swabbed with cotton wool soaked in distilled water.
- Time after start of exposure:
SCORING SYSTEM: Draize.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- There were no signs of skin irritation (only minimal erythema after one hour) in any of the animals.
- Other effects:
- None
Any other information on results incl. tables
ERYTHEMA AND ESCHAR FORMATION
1 hour 1,1,1
24, 48, 72 hours 0,0,0
OEDEMA FORMATION
No scored responses in any animal
Group total = 0, PDII = 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study conducted to OECD 404 and to GLP (reliability score 1), tetrasodium HEDP was not irritating to the skin of rabbits at a concentration of 30%.
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