[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

Five male and five female rats received a single dose of 3.1 or 5 ml Disflamoll DPK/kg bw by gavage. The animals were observed for mortality, clinical signs, and body weight. A gross pathological examination of the surviving rats was conducted randomly.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Not applicable

Molecular formula:

C19 H17 O4 P1

IUPAC Name:

Not applicable

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were housed in groups of 5 animals conventional in Macrolon cages type III on dust free wood granules at a temperature of 22+/- 1.5°C. Light/dark rythmus was 12 hours. and air humidity 60 +/- 55

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.0 ml/kg; 3.1 ml/kg bw.

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Mortality:

1 male animal died at a dose of 5 ml/kg bw.

Clinical signs:

other: Decreased general condition.

Gross pathology:

No findings.

Any other information on results incl. tables

Dose (ml/kg bw)	Sex	Mortality	No of animals	Animals with symtoms	start of symtoms	decrease of general condition
5,0	male	1	5	5	after 10 hours	yes
5,0	female	0	5	5	after 10 hours	yes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

In an acute oral toxicity test in 10 male and female Wistar rats the LD50 was >5000 ml/kg bw (5000 ml/kg bw = 6050 mg/kg bw; density = 1.21 mg/µg).

The decrease of general condition was the only symptom that was seen.