4-sec-butyl-2,6-di-tert-butylphenol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Results and discussion

Any other information on results incl. tables

SR08226 - Summarization

 

Oral doses of 4 -sec-butyl-2,6 -Di-tert-butylphenol by 0 (corn oil as control), 15, 60 and 250 mg/kg/day were applied to a group of Crl:CD(SD) rats consisting of 6 males and 6 females for 28 days to find out if or not it is toxic to the rat. Furthermore, for the doses of 0 and 250 mg/kg/day, a recovery group consisting of 6 males and 6 females were continuously observed for 14 days from the day following the last day of dosing.

The study gave the following results:

1. Under general status, both males and females are recognized with loose stool in case of the 250mg/kg dose group.

2. During the urine examination, the males in the 250mg/kg dose group are recognized to show significantly low urine pH values.

3. During blood examination, prothrombin time in case of the males in the group with dose beyond 60mg/kg, and thromboplastin time of the activated part in case of the males in the groups with doses beyond 60mg/kg and the females in the 250mg/kg dose group are recognized to be significantly extended.

4. During blood chemical examination, total cholesterin is recognized to have a significantly high value in case of the females in the groups with doses beyond 15mg/kg and the males in the groups with doses beyond 60mg/kg, the total bilirubinis recognized to have a significant high value in case of both males and females in the 250mg/kg dose group and AST, ALT, alkaline phosphatase and urea nitrogen are recognized to have significant high values while kalium and inorganic phosphorus are recognized to have significant low values in case of males, and the fraction ratio of α1-blobulin and creatinine are recognized to have significantly high values in case of females.

5. According to the anatomic examination, the watery content of caecum is recognized in case of the males in the 60mg/kg dose group, and both males and females in the 250mg/kg dose group.

6. For the organ weight, the relative weight of liver is recognized to have a significant high value in case of the females in the group with dose beyond 15mg/kg and the absolute weight is recognized to have a significant high value in case of the females in the 250mg/kg dose group.

7. According to the histopathologic examination, slight centrilobular liver cell hypertrophy is recognized in case of the females in the 250mg/kg dose group.

8. It is recognized that any of the changes recognized by 1-7 will get recovered.

9. No change related to the dose of test substance is recognized in detailed status observation, function inspection, weight and intake volume.

 

Therefore, the amount of 4-sec-butyl-2,6-Di-tert-butylphenol which will not deliver any impact (NOEL) is considered to be 15mg/kg/day in case of males and less than 15mg/kg/day in case of females under the conditions of this test.