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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:
2010
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

Constituent 1
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

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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