Alkyl-[2-(alkyl-substituted-phosphinoyl)-alkyl]-phosphinic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control,
microbiological controls at regular intervals)
- The animals were kept in groups / individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Food was withheld 16-19 h prior to administration
Dose volume: 10 mL/kg

No. of animals per sex per dose:

3 animals per step/dose

Details on study design:

Step 1 (starting dose): 300 mg/kg body weight -> no mortality
Step 2: 2000 mg/kg body weight
Step 3: 2000 mg/kg body weight
3 animals per step/dose
Observation period 14 d; body weight: day 1, 8, 15; clinical examination: daily; gross pathology at termination

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: Apathy, slightly reduced spontaneous activity, kyphosis, tremor, slight piloerection, half eyelid-closure; fully reversible within the same day.

Other findings:

Under the study conditions, a single oral application of the test item to rats at a dose of 300 mg/kg body weight was associated with no signs of toxicity or mortality. Furthermore, an oral application of the test item at a dose of 2000 mg/kg body weight was associated with signs of toxicity which were fully reversible within 4 hours to 24 hours post-dose.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the substance after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat): > 2000 mg/kg <= 5000 mg/kg bw.

Executive summary:

Under the study conditions, a single oral application of the test item to rats at a dose of 300 mg/kg body weight was associated with no signs of toxicity or mortality. Furthermore, an oral application of the test item at a dose of 2000 mg/kg body weight was associated with signs of toxicity which were fully reversible within 4 hours to 24 hours post-dose.

The median lethal dose of the substance after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat): > 2000 mg/kg <= 5000 mg/kg bw.