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Diss Factsheets

Administrative data

Description of key information

In two internal references on oral toxicity, the LD50 for rats is determined to be 940 ± 150 and 1100 ± 116 mg/kg. In three studies in mice, the oral LD50 has been reported to be 350 ± 30, 1030 ± 165, and 500 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No raw data are included (calculated LD values only). No data on the number of animals per dose group. No data on clinical signs or gross pathology.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice were exposed to five concentrations of test substance on five consecutive days. Mortalities were recorded daily during the dosing and 10 days after the last dose. Body weight was measured before the first dose and 24h after the 5th dose.
GLP compliance:
no
Test type:
other: no details on study design
Limit test:
no
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
Animals were exposed on 5 consecutive days and observed for 10 days after the last dose.
Doses:
125; 250; 600; 1000; 2000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Statistics:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 030 mg/kg bw

The mortalities are given in the table below, number of animals is not specified. No difference in body weight gain was observed between the groups from the beginning of the study to day 6, when the weights were recorded.

 

Dose (mg/kg)

Day 1

2000

100%

1000

40%

500

0%

250

0%

125

0%

Derived LD50 (mg/kg)

1030 ± 165*

* 24h after the 1stdose

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 is 1030 ± 165 mg/kg.
Executive summary:

The acute oral toxicity of menadione was tested in mice. The LD50 is 1030 ± 165 mg/kg, as determined 24h after the first dose.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No rough data are included (calculated LD values only). No data on the number of animals per concentrations. No data on clinical signs or gross pathology.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were exposed to five concentrations of test substance on five consecutive days. Mortalities were recorded daily during the dosing and in the end of the study, on day 10 after the last dose. Body weight was measured before the first dose and 24h after the 5th dose.
GLP compliance:
no
Test type:
other: no details on study design
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
Animals were exposed on 5 consecutive days and observed for 10 days after the last dose.
Doses:
125; 250; 500; 1000; 2000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Statistics:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 100 mg/kg bw

The mortalities are given in the table below, number of animals is not specified. No difference in body weight gain was observed between the groups from the beginning of the study to day 6, when the weights were recorded.

 

Dose (mg/kg)

Day 1

2000

100%

1000

40%

500

0%

250

0%

125

0%

Derived LD50 (mg/kg)

1100 ± 166*

* 24h after the 1stdose

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 is 1100 ± 166 mg/kg.
Executive summary:

The acute oral toxicity of menadione was tested in rats. The LD50 is 1100 ± 166 mg/kg, as determined 24h after the first dose.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No raw data are included (calculated LD values only). No data on the number of animals per concentrations. No data on clinical signs or gross pathology.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice were exposed to five concentrations of test substance on five consecutive days. The animals were observed during the dosing and 10 days after last dose. Body weight was measured before the first dose and 24h after the 5th dose.
GLP compliance:
no
Test type:
other: no study details provided
Limit test:
no
Specific details on test material used for the study:
no specific data given
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
The test substance was administered on 5 consecutive days and the animals were observed for 10 days after the last dose.
Doses:
31.25; 62.5; 125; 250; 500 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Statistics:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
350 mg/kg bw

The mortalities are given in the table below, number of animals is not specified. No difference in body weight gain was observed between the groups from the beginning of the study to day 6, when the weights were recorded.

 

Dose (mg/kg)

Day 1

500

100%

250

0%

125

0%

62.5

0%

31.25

0%

Derived LD50 (mg/kg)

350 ± 30*

* 24h after the 1stdose

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 is 350 ± 30 mg/kg.
Executive summary:

The acute oral toxicity of menadione was tested in mice. The LD50 is 350 ± 30 mg/kg 24h after the first dose.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No raw data are included (calculated LD values only). No data on the number of animals per concentrations. No data on clinical signs or gross pathology.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were exposed to five concentrations of test substance on five consecutive days. The animals were observed to 10 days after last dose. Body weight was measured before the first dose and 24h after the 5th dose.
GLP compliance:
no
Test type:
other: no study details provided
Limit test:
no
Specific details on test material used for the study:
no specific data given
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
The test substance was administered on 5 consecutive days and the animals were observed during the dosing and 10 days after the last dose for mortalities.
Doses:
125; 250; 500; 1000; 2000 mg/kg
No. of animals per sex per dose:
not specified
Control animals:
not specified
Statistics:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
940 mg/kg bw

The mortalities are given in the table below, number of animals is not specified. No difference in body weight gain was observed between the groups from the beginning of the study to day 6, when the weights were recorded.

 

Dose (mg/kg)

Day 1

2000

100%

1000

70%

500

0%

250

0%

125

0%

Derived LD50 (mg/kg)

940 ± 150*

* 24h after the 1stdose

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 is 940 ± 150 mg/kg.
Executive summary:

The acute oral toxicity of menadione was tested in rats. The LD50 is 940 ± 150 mg/kg, as determined 24h after the first dose.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No data on necropsy or clinical data signs reported. Animals observed up to 3 days.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice were exposed to menadione once by oral gavage and monitored up to 3 days after the dose.
GLP compliance:
no
Test type:
other: acute toxicity
Limit test:
no
Species:
mouse
Strain:
other: white mice
Sex:
not specified
Details on test animals or test system and environmental conditions:
Animal weight 18-20 g
Route of administration:
oral: gavage
Vehicle:
other: peanut or sesame oil
Remarks:
not specified, which was used for menadione
Details on oral exposure:
Administration orally through a blunt metal cannula; volume of administration 0.25 cc per 20g animal weight. The control animals received vehicle at 0.5 cc per 20 g of body weight.
Doses:
100; 200; 400; 600; 800; 1000; 1200 mg/kg
No. of animals per sex per dose:
20 mice (sex not specified)/dose
Control animals:
yes
Remarks:
20, received vehicle only
Details on study design:
Animals were exposed to the test item and observed frequently during the first 5 hours, and then once daily for 3 consecutive days.
Statistics:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
500 mg/kg bw

The following mortalities were reported, number of animals is not specified.

 

Dose (mg/kg)

Mortality

1200

100%

1000

100%

800

95%

600

50%

400

35%

200

0

100

0

Derived LD50 (mg/kg)

500
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Oral LD50 is 500 mg/kg.
Executive summary:

White mice (20/group) were exposed once to menadione dissolved in peanut or sesame oil at seven dose levels. The animals were observed up to three days after the dose; mortalities were counted and the LD50 was derived. The oral LD50 is 500 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
350 mg/kg bw
Quality of whole database:
Five reports on oral acute toxicity of menadione are available. All of these pre-guideline- and pre-GLP studies conducted in the 1970s and early 1940s are equally low in their reliability. Applying the weight-of-evidence principle, menadione is classified as GHS Acute toxicity category 4.

Additional information

Justification for classification or non-classification

Five reports on oral acute toxicity of menadione are available. In two internal references, the LD50 for rats is determined to be 940 ± 150 and 1100 ± 116 mg/kg. In three studies in mice, the oral LD50 has been reported to be 350 ± 30, 1030 ± 165, and 500 mg/kg. All of these pre-guideline- and pre-GLP studies conducted in the 1970s and early 40s are equally low in their reliability. Applying the weight-of-evidence principle, menadione is classified as GHS Acute toxicity category 4.