Reaction mass of methyl dihydrogen phosphate and orthophosphoric acid and dimethyl hydrogen phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Apr 1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study design similar to OECD 401 with deviations and restricted reporting

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

7 days recovery, females tested

GLP compliance:

no

Remarks:

performed before GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reinigerkomponente M - spezial

IUPAC Name:

Reinigerkomponente M - spezial

Test material form:

other: liquid

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 99.6 g (mean)
- Fasting period before study: 12 h
- Diet (e.g. ad libitum): Standard Altorim R (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%

Doses:

1.0; 1.6; 2.5; 4.0 or 6.3 mL/100 g bw
according to
1055; 1688; 2638; 4200 or 6647 mg/kg bw ((assuming a density of 1.055 g/cm3 in case of a 10% solution)

No. of animals per sex per dose:

10 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days

Statistics:

LD50 derivation according Kärber method

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2.55 other: (10% solution)/100 g bw

Remarks on result:

other: corresponding to 2690 mg/kg bw/d

Mortality:

Dose: 1055 mg/kg bw; Mortality rate: 0/10
Dose: 1688 mg/kg bw, Mortality rate: 3 / 10
Dose: 2638 mg/kg bw, Mortality rate: 4 / 10
Dose: 4220 mg/kg bw, Mortality rate: 10 / 10
Dose: 6647 mg/kg bw, Mortality rate: 10 / 10

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

no data

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 testsubstance was 2690 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements 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 1055, 1688, 2638, 4220 or 6647 mg/kg bw and observed for 7 days.

The median lethal dose was 2690 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements according to regulatory requirements.