4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

EC Number:

421-750-9

EC Name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Cas Number:

57280-22-5

Molecular formula:

C7H12O3

IUPAC Name:

4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Mol:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding Centre Ltd, Ejby, DK-4623 Ll. Skensved.
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 144-151 g
- Fasting period before study: 18 h
- Housing: The rats were individually ear-tagged and kept in Macrolone cages Type III (42 x 26 x 15 cm) 2 or 3 to a cage,· males and females separated. The bedding was softwood sawdust "Spanvall' Special White 11 from Spanvall Ltd, Jorlose, DK-4490 Jerslev.
- Diet (e.g. ad libitum): ad libitum, complete rodent diet ."Altromin 1314" from Chr. Petersen Ltd, DK-4100 Ringsted
- Water (e.g. ad libitum): tap water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: None

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 2
- Humidity (%): 55+/-15
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: 1, 3 and 6 hours after administration and thereafter daily; weighing on day 0, 7, 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other:

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Since no rats died of the treatment the oral LD50 must exceed 2000 mg ",4,4-dimethyl-3,5;8-trioxabicyclo(5.1.0)octane"/kg b. wt.. According to Regulation (EU) No. 1727/2008 (CLP) the substance does not need to be classified with respect to acute oral toxicity.

Executive summary:

In an acute oral toxicity study according to OECD test guideline 401 (1987), groups of fasted, Wistar rats (5/sex) were given a single oral dose of 4,4-dimethyl-3,5;8-trioxabicyclo(5.1.0)octane in water at a dose of 2000 mg/kg bw and observed for 14 days.

Oral LD50 Females/Males > 2000 mg/kg bw

 

After single oral administration of 4,4-dimethyl-3,5;8-trioxabicyclo(5.1.0)octane at 2000 mg/kg bw to male and female rats (5/sex/group) sedation and piloerection were found as clinical signs. At autopsy, no gross pathological organ changes were observed.

4,4-dimethyl-3,5;8-trioxabicyclo(5.1.0)octane is of LOW Toxicity based on the LD50 in female and male Wistar rats, thus, 4,4-dimethyl-3,5;8-trioxabicyclo(5.1.0)octane is not classified for acute oral toxicity according to Regulation (EU) No. 1272/2008 (CLP).