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Diss Factsheets

Administrative data

Description of key information

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.

Based ont he result of a 14 day dose range finding study (NOAEL 800 mg/kg bw/d, the highest dose tested) with diethylphosphinic acid (source substance) the LD 50 is considered to be above 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
fully OECD compliant guideline studies performed with source substances

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

none

Justification for classification or non-classification

Due to the results described in the acute oral and 14 day dose range finding study (LD50oral in rats > 2000 mg/kg bw; NOAEL 800 mg/kg bw/d, highest dose tested) the substance does not have to be classified as acute orally toxic.