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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 to 18 September 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken to GLP and internationally recognised guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
The air conditioner in the animal room did not work due to a lightning strike. The humidity was beyond the acceptable range (maximum: 77.3%) for 24 minutes on August 29, 2008. This deviation is not considered to have affected the study.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Phenylphosphonic Acid, Zinc Salt
IUPAC Name:
Phenylphosphonic Acid, Zinc Salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Phenylphosphonic Acid, Zinc Salt (II)
- Substance type: Inorganic
- Physical state:White powder
- Analytical purity: > 99%
- Lot/batch No.: 6415
- Expiration date of the lot/batch: End of August 2009
- Storage condition of test material: Dark and cold place (Actual temperature: 3.4 to 6.3°C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 8 weeks old
- Weight at study initiation: 135 to 147 g
- Fasting period before study: Yes
- Housing: Polycarbonate flat-bottom cages (W260 x D420 x H180 mm, Natsume Seisakusho Co., Ltd.)
- Diet (e.g. ad libitum): Pellet diet MF (Lot No. 080522, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): Tap water supplied by the local government was filtered through a 5-f.lm cartridge filter, and was sterilized with an ultraviolet water sterilizer.
- Acclimation period: For 7 days or longer after arrival

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Actual measurement values, 23.1 to 24.5°C (set at 23°C; acceptable range, 20.0 to 26.0°C)
- Humidity (%): Actual measurement values, 40.7 to 77.3%RH (set at 50%RH; acceptable range, 30.0 to 70.0%RH)
- Air changes (per hr): 17 air changes/hour (all-fresh-air ventilation)
- Photoperiod (hrs dark / hrs light): Artificial lighting, with a sequence of 12 hours on (between 6:00 a.m. and 6:00 p.rn.) and 12 hours off

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 w/v% solution.
- Amount of vehicle (if gavage): 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test substance was initially administered at dose of 2,000 mg/kg because no
animals died after administration of the test substance at 2,000 mg/kg in the non-GLP study (Study No.: N06122).
Doses:
2,000 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: On day, 0, 1, 2, 3, 4, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:
None
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: None
Gross pathology:
There were no abnormalities of the appearance, and macroscopic examination of the cranial, thoracic, and abdominal cavities and lymph nodes revealed no abnormalities in any organ in both the first or second dosing group.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No animals died at 2,000 mg/kg either in the first or second dosing group. No abnormalities were observed in the general condition, such as appearance, posture and behavior of dosed animals. Body weight increased satisfactorily from the day after administration, and weight gain during the 14-day observation period was 31 to 38 g (mean: 35.3 g), which seemed to be normal (background data: 27 to 41 g). Necropsy revealed no changes suggesting the influence of the test substance administration.
The test substance did not show any toxicity at dose level of 2,000 mg/kg, and thus the LDso was more than 2,000 mg/kg. This result indicates that the test substance is classified as a "Category 5/Not classified" substance according to the GHS classification.
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