Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose:
reference to same study

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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aluminum Ammonium Superphosphate (Batch No. 38771-55-3), a white powder stored at room temp in a dark, dry, closed container.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
The rats were supplied by Harlan Laboratories UK Limited. On receipt the animals were randomly allocated to cages.
Acclimatisation period: At least 5 days. Animals were selected randomly and given a number unique within the study and identified by a number written on a cage card.
Age at the beginning of the study: 8-12 weeks. Bodyweights: +- 20% of the mean weight of any previously dosed animals.
With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
Temperature and relative humidity: 19-25°C and 30-70% respectively.
Rate of air exchange: At least 15 changes per hours.
Lighting: 12h continuous light & 12h darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each individual animal to confirm the outcome of the previously dosed animals. The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days.
Bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
Doses:
175 mg/kg, 550 mg/kg, 2000 mg/kg
No. of animals per sex per dose:
5 females total:
1 female per the smaller dose of 175 mg/kg
1 female per 550 mg/kg
3 females per the higher concentration of 2000 mg/kg
Control animals:
no
Details on study design:
For the purpose of the study the test material was freshly prepared, as a suspension at the appropriate concentration in distilled water. The test material was formulated within 2 hours of being applied to test system. It was assumed that the formulation was stable for this duration.

No information was available regarding the toxicity of the test material therefore the default values for LD50 and sigma were entered into AOT425 Statistical Program. The program gave a recommended dose progression of 2000, 550, 175, 55, 17.5, 5.5 and 1.75 mg/kg.
The first animal was dosed at 175 mg/kg. Further animals were then treated based on the short-term results of the previously treated animal. The test was complete after the fifth animal had been dosed as the following criterion was met: - three consecutive animals survived at the maximum dose level (2000 mg/kg).

At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
The oral LD50 was calculated by maximum likelihood method. Data evaluations also included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.

Results and discussion

Preliminary study:
No
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
Hunched posture was noted in all animals. Tiptoe gait was also noted in one animal treated at a dose level of 550 mg/kg. All animals appeared normal one day after dosing.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necroscopy.
Other findings:
no further information

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Wistar strain rat. 5 females were dosed at dose levels ongoing from 175 mg/kg bw to 2000 mg/kg bw. No deaths occurred and no abnormalities were noted. LD50 was found to be greater than 2000 mg/kg bodyweight.