Registration Dossier
Registration Dossier
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EC number: 701-238-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- EC Number:
- 701-238-4
- Cas Number:
- 29329-71-3
- Molecular formula:
- HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
- IUPAC Name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Females nulliparous and non-pregnant: Not specified
- Rationale for use of males: N/a
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Fasting period before study: Not specified
- Housing: Animals were kept in 3 Makrolon cages, individually housed.
- Historical data: Not specified
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Not specified
- Microbiological status when known : Not specified
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): As recommended in the guideline
- Humidity (%): As recommended in the guideline
- Air changes (per hr): As recommended in the guideline
- Photoperiod (hrs dark / hrs light): As recommended in the guideline
IN-LIFE DATES: Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2510, 3160, 3570, 3980 mg/kg at 20ml/kg
- No. of animals per sex per dose:
- 10 females in total
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 550 mg/kg bw
- Remarks on result:
- other: equivalent to 2925 mg/kg bw/day active acid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study, conducted to a protocol similar to the now deleted OECD Test Guideline 401 and pre-GLP, HEDP (2-3Na) was administered by oral gavage to female rats. An LD50 of 3550mg/kg which is equivalent to 2925 mg/kg bw/day active acid was concluded.
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