Registration Dossier
Registration Dossier
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EC number: 701-438-1 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 2010 - 21 July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to official EC and OECD test guidelines, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002-12
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of diiron carbide, diiron phosphide and triiron phosphide
- EC Number:
- 701-438-1
- Cas Number:
- not applicable
- Molecular formula:
- not applicable (multi constituent substance)
- IUPAC Name:
- Reaction mass of diiron carbide, diiron phosphide and triiron phosphide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD 'SD'
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 190 - 231 g
- Fasting period before study: not specified
- Housing: Animals were housed in groups of three rats of the same sex, in solid bottomed polycarbonate cages with a stainless-steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Historical data: not specified
- Diet (e.g. ad libitum): standard rodent diet (Rat and Mouse No. 1 Maintenance Diet); ad libitum (except for overnight prior to and approximately four hours after dosing)
- Water (e.g. ad libitum): Potable water taken from the public supply; ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% (w/v) aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw (total dose volume)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels for the study were chosen in compliance with the study guidelines. As no
previous toxicological information was available the initial dose level was 300 mg/kg. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: yes
- Clinical signs including body weight - Statistics:
- No statistical analysis was performed on this study.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: Clinical signs of reaction to treatment comprised faeces abnormal colour (black) seen in all females dosed at 300 mg/kg and three females (A7, A8 and A9) dosed at 2000 mg/kg. These signs were first noted approximately thirty minutes or two hours after dos
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of Ferrophosphorus (Fe3P) was demonstrated to be greater than 2000 mg/kg bodyweight.
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