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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
October 6-26, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, GLP-compliant, according to OECD 425 in rat. Purity test substance unknown. For justification of read-across see CSR chapter 1.3.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Analytical purity: (P205) Available Phosphoric Acid 46.86% and Total Nitrogen 17.93%
- Stability under test conditions: expected to be stable under test conditions and duration of study
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on September 19 and 26, 2000
- Age at study initiation: Young adult (9-11 weeks)
- Weight at study initiation: males 275-310 grams and females 195-230 grams
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in
the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least
three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 13 or 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature Range: 18-22ºC
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
An initial dose of 2000 mg of the test substance per kilogram of bodyweight was administered to one healthy female rat by oral gavage. Due to the
absence of mortality in this animal a second female received the same dose level. Following the completion of dosing and 100% survival in a total of
three females, a group of three males was tested (simultaneously) at the above dose level. Prior to use, the test substance was ground in a coffee mill and administered by gavage as a 70% w/w suspension in distilled water (preliminary solubility testing indicated that suspension in excess of 70% were too viscous to be administered properly).
Doses:
1 x 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to administration and again on Days 7 and 14 (termination) after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
No data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived
Clinical signs:
Animals appeared active and healthy throughout the study period
Body weight:
Animals gained weight
Gross pathology:
FEMALES: All tissues/organs No gross abnormalities
MALES: All tissues/organs No gross abnormalities
Other findings:
No data

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No signs of toxicity were observed. LD50 > 2000 mg/kg.
Executive summary:

Acute toxicity of the test material was determined according to OECD TG 425 and GLP.

In total 3 female and 3 male sprague-dawley rats were administered 2000 mg/kg bw test substance by gavage and observed for 14 days. All animals survived, appeared active and healthy throughout the study period, gained weight and did not show gross abnormalities in necropsy and histopathology. Other findings were not reported. Therefore, the test substance did not seem to cause signs of toxicity in rats at the tested dose. It is concluded that the acute oral LD50 in rats is above 2000 mg/kg bw.