Registration Dossier
Registration Dossier
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EC number: 609-080-7 | CAS number: 35160-38-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6-10 weeks
- Weight at study initiation: males -195 g, females: 178 g
- Fasting period before study: 16 hours before to 3-4 hours after treatment
- Housing: in macrolon cages (type 4) in groups of 5
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 C°
- Humidity (%): 50+/-20%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 10. March To: 24. March 1998
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil DAB 10
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: solubility
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical symptoms: twice daily
body weight: weekly
- Necropsy of survivors performed: yes - Statistics:
- n.a.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- no symptoms observed
- Body weight:
- not impaired
- Gross pathology:
- no changes
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- Based on the results obtained with phosphinic acid, diethyl, aluminium salt (source substance) the LD 50 is greater than 2000 mg/kg bw. The substance does not have to be classied according to EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Acute oral toxicity testing of phosphinic acid, diethyl, aluminium salt (source substance) in the rat yielded a LD50 above 2000 mg/kg bw in both male and female animals.After admimistration of 2000 mg/kg bw neither deaths nor symptoms occurred.
Development of body weight was not impaired.
The animals killed at the end of the observation period showed no macroscopically visible changes.
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