Registration Dossier
Registration Dossier
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EC number: 251-908-0 | CAS number: 34274-28-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.03.1995 to 18.04.1995
- 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 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [nitrilotris(methylene)]trisphosphonic acid, ammonium salt
- EC Number:
- 251-908-0
- EC Name:
- [nitrilotris(methylene)]trisphosphonic acid, ammonium salt
- Cas Number:
- 34274-28-7
- Molecular formula:
- C3H12NO9P3.xH3N
- IUPAC Name:
- ammonium hydrogen {[bis(phosphonomethyl)amino]methyl}phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: Males: 148-165 g; Females: 132-157 g.
- Fasting period before study: Overnight
- Housing: Groups of five in solid-floor polypropylene cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27.03.1995 To: 18.04.1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:1.63 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity at 30 minutes, one, two and four hours after dosing, and then once daily for 14 days. Body weights were recorded prior to dosing and on Day7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology. - Statistics:
- Not required.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no clinical signs of toxicity.
- Gross pathology:
- No abnormal findings.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP, acute oral toxicity (limit) study (reliability score 1) conducted according to the now deleted OECD 401, the LD50 for undiluted ammonium salt of ATMP was greater than 2000 mg/kg bw in rats.
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