Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(March 1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

434-070-2

EC Name:

-

Cas Number:

268567-32-4

Molecular formula:

C12 H25 O4 P S2

IUPAC Name:

3-{[bis(2-methylpropoxy)(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}-2-methylpropanoic acid

Test material form:

liquid: viscous

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (17 - 23°C) away from direct sunlight
- Stability under test conditions: substance was found to be homogeneously distributed in PEG 300 and stable for at least 2 hours at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain as stated in report: HanIbm: WIST (SPF)
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllingsdorf / Switzerland
- Age at study initiation: Females 10 weeks, males 8 weeks
- Bodyweight at study initiation: Female: 175 - 187 g, males 207 - 222 g
- Fasting period before study: 16 hours
- Housing: Groups of 3 in Makrolon type-4 cages
- Diet (e.g. ad libitum): Pelleted Standard Kliba 3433, rat maintenance diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimatisation: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr):10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

The test article was suspended in vehicle at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg BW by oral gavage. Test article was mixed with vehicle using a magnetic stirrer as homogenizer. Homogeneity of test article in the vehicle was maintained during treatment. The preparation was made shortly before each using.

Doses:

2000 mg/kg BW

No. of animals per sex per dose:

3 males and 3 females were dosed as described above.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times on first day, afterwards once daily
- Frequency of weighing: On first day, day 8 and day 15
- Necropsy of survivors performed: yes, all animals were sacrificed and subjected to gross pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One of three females was found dead 3 hours after treatment. None of the treated males died.

Mortality:

One of three females was found dead 3 hours after treatment. None of the treated males died.

Clinical signs:

other: Ruffled fur, ventral position and convulsions were observed in the one female before it died. A relation to the application method can not be excluded. No clinical signs were noted during the observation period in all other animals.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Body weight of male and female rats following single oral administration of 2000 mg/kg bw of test article

Body weight in grams:
Sex	Animal No.	Day of Treatment	Day 8	Day 15
Female	1	183.4	*
	2	175.0	192.9	203.4
	3	186.7	199.8	207.3
Male	4	206.9	258.5	291.1
	5	222.3	278.3	316.9
	6	215.8	263.5	291.8

* animal died

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met