Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.03.1995 to 18.04.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): AMGARD RD1
- Substance type: Phosphonic acid (ammonium salt)
- Physical state: Straw-coloured liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: 20.02.95
- Expiration date of the lot/batch:No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: Males: 148-165 g; Females: 132-157 g.
- Fasting period before study: Overnight
- Housing: Groups of five in solid-floor polypropylene cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 27.03.1995 To: 18.04.1995

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:1.63 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity at 30 minutes, one, two and four hours after dosing, and then once daily for 14 days. Body weights were recorded prior to dosing and on Day7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology.
Statistics:
Not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
No effects.
Gross pathology:
No abnormal findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP, acute oral toxicity (limit) study (reliability score 1) conducted according to the now deleted OECD 401, the LD50 for undiluted ammonium salt of ATMP was greater than 2000 mg/kg bw in rats.
Executive summary:

In a GLP, acute oral toxicity (limit) study (reliability score 1) conducted according to the now deleted OECD 401, the LD50 for undiluted ammonium salt of ATMP was greater than 2000 mg/kg bw in rats.