Phosphoric acid, dodecyl ester, potassium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sept 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to OECD401; performed before GLP.

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

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, dodecyl ester, potassium salt

EC Number:

254-414-3

EC Name:

Phosphoric acid, dodecyl ester, potassium salt

Cas Number:

39322-78-6

Molecular formula:

not applicable

IUPAC Name:

potassium dodecyl hydrogen phosphate

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 mg/kg
8000 mg/kg
9000 mg/kg
10000 mg/kg
12500 mg/kg
15000 mg/kg

No. of animals per sex per dose:

10 females

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

Sex:

female

Dose descriptor:

LD50

Effect level:

10 490 mL/kg bw

95% CL:

> 9 833 - <= 11 191

Mortality:

Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 8000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 9000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 10000 mg/kg bw, Mortality rate: 5 / 10
Sex: female, Dose: 12500 mg/kg bw, Mortality rate: 9 / 10
Sex: female, Dose: 15000 mg/kg bw, Mortality rate: 10 / 10

Clinical signs:

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

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

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the test item (LD50) was 10490 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.