Registration Dossier

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:
other: 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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD "SD"
Sex:
female
Details on test animals and environmental conditions:
The animals were allocated without conscious bias to cages within the treatment groups.
They 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. Cages, food hoppers, water bottles and bedding were changed at appropriate
intervals.
Each animal was assigned an alpha-numeric code and identified uniquely within the study by
tail marking. Each cage label was colour-coded and was identified uniquely with the study
number, dose level and animal mark.
The animal room was kept at positive pressure with respect to the outside by its own supply
of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature
and relative humidity controls were set to maintain the range of 19 to 23°C and 40 to 70%
respectively. Any minor deviations from these ranges would not have had an adverse effect
on the animals and would not affect the integrity or validity of the study. Artificial lighting
was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per
24 hours.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% (w/v) aqueous methylcellulose
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
The test substance was formulated at concentrations of 30 and 200 mg/mL in the vehicle and
administered at a volume of 10 mL/kg bodyweight.
The test substance formulations were prepared on the day of dosing.
The animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1
Maintenance Diet), except for overnight prior to and approximately four hours after dosing.
This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Potable water taken from the public supply was freely available via polycarbonate bottles
fitted with sipper tubes.
During the acclimatisation and study periods, each cage of animals was provided with a soft
white untreated chew block and a plastic shelter for environmental enrichment.
The absorption of the test substance was not determined.
Determination of the homogeneity, stability and purity of the test substance or test substance
formulations were not undertaken as part of this study.
Detailed records of test substance usage were maintained. The amount of test substance
necessary to prepare the formulations and the amount actually used were determined on each
occasion. The difference between these amounts was checked before the formulations were
dispensed.

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:
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 dosing, and had
resolved by Day 2.
Body weight:
A low bodyweight gain was recorded between Days 8 – 15 for two females (A1, A2) dosed at
300 mg/kg and three females (A9, A10, A12) dosed at 2000 mg/kg.
All remaining animals were considered to have achieved satisfactory bodyweight gains
throughout the study.
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:
not classified
Remarks:
Migrated information 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.