Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only study summary available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): divinylether of 1,4 cyclohexane, dimethanol
- Physical state: liquid
- desity: 0,96 g/ml

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Camm Research (Wayne; NJ USA)
- Weight at study initiation: 190-220 g
- Fasting period before study: 18 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18,3-23,9 (65-75 °F)
- Photoperiod (hrs dark / hrs light): 12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg
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 were 1, 3 and 6 h post application, once daily there after. Weighing was prior to application and at termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
4 of 10 animals died.
day 0 -1: no death occurred
day 2: one male
day 3: one male; one female
day 4: one female
day 5 -14: no death occurred
Clinical signs:
Slight to severe depression of activity was noted for 5 animals. One animal appeard dehydrated on the second and the third day. Muscle tremor was noted for two animals on the second day.
Body weight:
Body weight development in the surviving animals was positive. Body weight of animals found dead was reduced in comparison to the beginning of the study.
Gross pathology:
No pathological changes were observed at necropsy of the surviving animals. Gastrointtestinal irritation and motteld to bleached liver lobes was observed in the animals found dead.

Applicant's summary and conclusion

Executive summary:

Oral toxicity was examined in a guidline study similar to OECD 401. The study is reliable with some minor restriction mainly due to poor documentation of the test substance. Male and female Wistar rats recieved a limit dose of 5000 mg/kg. 4 (2 m/2f) animals died. The LD 50 therfore is > 5000 mg/kg. Gastrointestinal irritation and mottled liver lobes were observed at necropsy.

Conclusion

Dimethanol-divinyl ether of 1,4- cyclohexane is practically non-toxicic after swallowing.