2,4,6-trimethyl-1,3,5-trioxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 August 1982 - 15 September 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with international guidelines.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trimethyl-1,3,5-trioxane

EC Number:

204-639-8

EC Name:

2,4,6-trimethyl-1,3,5-trioxane

Cas Number:

123-63-7

Molecular formula:

C6H12O3

IUPAC Name:

2,4,6-trimethyl-1,3,5-trioxane

Test material form:

other: yellowish clear liquid

Details on test material:

Label: P0086
Storage: at RT, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Screening study:
---------------
50, 250, 1250 and 5000 mg/kg

Single dose level study:
---------------------
2000, 2830, 4000 and 5660 mg/kg

No. of animals per sex per dose:

Screening study:
---------------
Four groups, each of 2 fasted rats (1 male, 1 female)

Single dose level study:
---------------------
One group of 10 fasted rats (5 males, 5 females)

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 711 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 852 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 529 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Screening study:

The mortalities indicated an LD50 in the range 1250 mg/kg - 5000 mg/kg.

Single dose level study:

A total of 26 (12 male, 14 female) of the 40 animals died during the study period. The majority of deaths occurred during the day of dosing. All remaining deaths were noted 24 hours after treatment.

Major signs of toxicity were prostration, lethargy and lacrimation. All surviving animals showed body weight gains at the end of the study period. Major pathological findings were associated with the lungs, which appeared pale in colour with occasional red speckles.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of P0086 in the Wistar-derived rat was estimated to be 2711 mg/kg bodyweight.

Executive summary:

The acute oral toxicity study was performed from August 1982 - September 1982 according to OECD Guideline 401 and GLP.

A total of 26 of the 40 animals died during the study period. Major signs of toxicity were prostration, lethargy and lacrimation. All surviving animals showed body weight gains at the end of the study period. Major pathological findings were associated with the lungs, which appeared pale in colour with occasional red speckles.

The acute oral median lethal dose (LD50) of P0086 in the Wistar-derived rat was estimated to be 2711 mg/kg bodyweight.