Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(only basic information given)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate

EC Number:

224-580-1

EC Name:

Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate

Cas Number:

4418-26-2

Molecular formula:

C8H7O4.Na

IUPAC Name:

sodium 1-(6-methyl-2,4-dioxo-2H-pyran-3(4H)-ylidene)ethanolate

Test animals

Species:

mouse

Strain:

other: Tylers Original

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20 ± 2
- Fasting period before study: overnight
- Housing: in solid floor polycarbonate boxes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Photoperiod: natural lighting conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL solution

Doses:

500, 1000, 1500, 2000 and 2500 mg/kg bw (and also 5000 mg/kg bw in the preliminary study).

No. of animals per sex per dose:

2 in preliminary study
10 in main study

Control animals:

no

Details on study design:

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

Results and discussion

Preliminary study:

A rangefinding trial was performed with 2 animals per dose (500, 1000, 2500 and 5000 mg/kg bw)
500 and 1000 mg/kg bw: no deaths occured
2500 mg/kg bw and more: all animals died on Day 1

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 175 mg/kg bw

Based on:

test mat.

95% CL:

>= 987 - <= 1 410

Mortality:

For details refer to Table 1 under "any other information on results".

Clinical signs:

other: 500 mg/kg bw and more: convulsions and stretching within 90 min of dosing, symptoms less severe in survivors after 48 h, asymptomatic after 72 h

Any other information on results incl. tables

Table 1 Acute oral toxicity: main study data for Day 14 only

Dose	Mortality on Day 14
[mg/kg bw]
	N*
Males/Females
500	0/10
1000	6/10
1500	8/10
2000	9/10
2500	10/10

Table 2 Acute oral toxicity in the mouse: combined preliminary and main study data

Dose mg/kg bw	Mortality on Day 4 (No.)
500	0/12
1000	6/12
1500	6/12
2000	8/10
2500	11/12

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 = 1175 mg/kg bw.

Executive summary:

The LD50 in the mouse was 1175 mg/kg bw.