Ditolyl ether

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientific acceptable and well documented

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: 84/449/EWG

Principles of method if other than guideline:

5 male mice, 5 male hamster and 6 male and female guinea received a single oral application per gavage of 200 or 2000 mg/kg bw of the test substance. Post-exposure period was 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ditolyl ether

EC Number:

248-948-6

EC Name:

Ditolyl ether

Cas Number:

28299-41-4

Molecular formula:

C14H14O

IUPAC Name:

Benzene, 1,1'-oxybis[methyl-

Details on test material:

purity: 99.1%

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male

Details on test animals or test system and environmental conditions:

according to their weight animals were 10 to 13 weeks old at the start of the study. husbandry: standardised conditions, animals were housed in makrolon cages

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: physiol. saline/Cremophor 2%

Details on oral exposure:

16 hours before and 4 hours after the application of the test substance the animals were fastened

Doses:

200, 2000 mg/kg bw

No. of animals per sex per dose:

5 male mice per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the post observation period of 14 days animals were inspected twice daily (daily on weekend) and time of onset, duration, and severity of clinical signs recorded, animals were weighened before, after 1 week and at the end of the post-observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

not applicable - estimation of the mean lethal dose on the basis of the dosage of 200 and 2000 mg/kg bw

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

200 - 2 000 mg/kg bw

Mortality:

dose 200 mg/kg bw, mortality 0/5; dose 2000 mg/kg bw, mortality 5/5

Clinical signs:

other: a dose of 200 mg/kg bw was tolerated without symptoms. with 2000 mg/kg bw all mice revealed sedation, apathy and tremor on the same day of application of the test substance

Gross pathology:

some of the animals killed at the end of the experiment revealed sparse collapsed lungs. 2 out of 5 mice administered a dose 2000 mg/kg bw revealed changes of stomach and/or intestines (black and red colored areas of the stomach mucosa and black-brown discoloration of the intestine contents

Other findings:

a dose of 2000 mg/kg bw caused in some animals a storage of fine droplets of fat in the hepatocytes

Any other information on results incl. tables

Mortality 0/5 after administration of 200 mg/kg bw,
Mortality 5/5 after administration of 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Executive summary:

Method: 5 male mice received a single oral application per gavage of 200 or 2000 mg/kg bw of the test substance. Post-exposure period was 14 days.

Result: LD50 = 200 - 2000 mg/kg bw (B6C3F1 -mouse); mortality 0/5 after administration of 200 mg/kg bw mortality, Mortality 5/5 after administration of 2000 mg/kg bw; with 2000 mg/kg bw all mice revealed sedation, apathy and tremor on the same day of application of the test substance

Reference: Bomhard/Groening (Bayer AG), 1990