Phosphoric acid, mono- and di-isotridecyl esters, potassium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only one sex tested, limitations in study reporting

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Type:

Constituent

Type:

Constituent

Type:

Constituent

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Test animals:
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

Environmental conditions:
- Housing: in groups, in plastic cages, softwood pellets

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Concentration in vehicle: 25 % (w/v)

Doses:

6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

Probit analysis (method by Linder and Weber); Confidence limits according to Cavalli-Sforza

Results and discussion

Preliminary study:

Preliminary experiments did not show differences related to gender. Therefore only females used for main study.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

10 490 mg/kg bw

Based on:

test mat.

95% CL:

> 9 833 - <= 11 191

Remarks on result:

other: corresponding to 2623 mg a.i./kg bw

Remarks:

with a concentration correction of 25%

Mortality:

Mortality rate:
- 6300 mg/kg bw: 0 / 10
- 8000 mg/kg bw: 0 / 10
- 9000 mg/kg bw: 0 / 10
- 10000 mg/kg bw: 5 / 10
- 12500 mg/kg bw: 9 / 10
- 15000 mg/kg bw: 10 / 10

Clinical signs:

Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.

Body weight:

Normal body weight gain was observed in all surviving animals.

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed following macroscopic findings: stomach and oesophagus were filled with white foam.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (oral: gavage).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD guideline 401 (standart acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once weekly. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisened animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was vomitted. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Under the study conditions, the female rat LD50 of the test substance was determined to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (1974).