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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted by GLP accredited laboratory using OECD Guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
EC Number:
212-985-6
EC Name:
2,2'-isopropylidenebis(p-phenyleneoxy)diethanol
Cas Number:
901-44-0
Molecular formula:
C19H24O4
IUPAC Name:
2-(4-{2-[4-(2-hydroxyethoxy)phenyl]propan-2-yl}phenoxy)ethan-1-ol
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
At the start of the main study, the males weighed 154 - 180 g, and the females 126 - 136 g, were approximately five to eight weeks old.
The animal room was maintained at a temperature of 19 - 22°C and relatve humidity of 46 - 58%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Exposure period of 14 days
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Preliminary study:
A range-finding study was conducted using 1 female and 1 male rats to establish the dose regime. The dose level was 2000 mg/kg, the concentration was 200 mg/ml and the dose volume was 10 mg/kg. Overt signs or deaths were observed 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days. There were no deaths or clinical signs of toxicity. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was recorded.
Clinical signs:
Common signs of hunched posture were noted with additional signs of ataxia, lethargy and decreased respiratory rate.
Animals recovered one day after dosing except for two males which appeared normal throughout the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be > 2000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity of the test substance to Sprague-Dawley rats was determined in accordance with the OECD Guideline for Testing of Chemicals 401. The rats were exposed to a dose of 2000 mg/kg bw of the test substance via oral gavage route. No mortality was observed and the acute oral median lethal dose (LD50) of the test material was found to be > 2000 mg/kg bodyweight. The test substance is not classified for acute oral toxicity.