Phosphoric acid, mixed esters with Bu alc. and ethylene glycol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7. Apr – 28. Apr 1976

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

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:

Knapsack-Reinigerkomponente GB LP Kn 164

IUPAC Name:

Knapsack-Reinigerkomponente GB LP Kn 164

Test material form:

liquid: viscous

Details on test material:

colorless viscous liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation 88-111 g:
- Fasting period before study: 16 h
- Housing: in Macrolon cages with softwood bedding
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

concentration in vehicle: 10 %

Doses:

1600, 2500, 3200, 4000 or 5000 mg/kg bw

No. of animals per sex per dose:

10 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations daily 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:

3 575 mg/kg bw

95% CL:

> 3 306 - <= 3 865

Mortality:

Dose: 1600 mg/kg bw, Mortality rate: 0 / 10
Dose: 2500 mg/kg bw, Mortality rate: 0 / 10
Dose: 3200 mg/kg bw, Mortality rate: 2 / 10
Dose: 4000 mg/kg bw, Mortality rate: 8 / 10
Dose: 5000 mg/kg bw, Mortality rate: 10 / 10

Clinical signs:

other: closed eye lid, abnormal breathing, crouched posture Mortally poisened animals died within 1-2 days after application.

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 mucosa reddened, stomach filled with bloody content

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 was 3575 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.

Executive summary:

The test item was tested for its acute oral toxicity potential. 10 female rats were treated with doses of 1600, 2500, 3200, 4000 or 5000 mg/kg bw and observed for 14 days.

The median lethal dose of test item (LD50) was 3575 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.