3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 December to 20 December 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken by a GLP accredited laboratory to an internationally recognised method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

T-1215A

IUPAC Name:

T-1215A

Constituent 2

Reference substance name:

3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide

EC Number:

700-596-9

Cas Number:

14442-94-5

Molecular formula:

C35H63NO2

IUPAC Name:

3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide

Constituent 3

Reference substance name:

3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide

IUPAC Name:

3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide

Details on test material:

- Name of test material (as cited in study report): T-1215A (3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide)
- Substance type:Solid
- Physical state: Powder
- Analytical purity: 97.1% (measured by GC)

- Impurities (identity and concentrations):
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-hexadecyl-propionamide; 1.3%
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-heptadecyl-propionamide; 1.6%

- Purity test date: 28 October 2004
- Lot/batch No.: 04HY1101
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Other:

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 205 - 239 g
- Fasting period before study: Overnight immediately before dosing and 3 to 4 hours after dosing.
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2), ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12 hours light, 0600h to 1800h and 12 hours darkness.

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/ml

DOSAGE PREPARATION (if unusual): No data

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using all available information on the toxicity of the test material, 2000 mglkg was chosen as the starting dose.

Doses:

One dose of 2000 mg/ml

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, l, 2 and 4 hours after dosing
and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross pathological examination. This consisted of an extemal examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

None

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Organ weights: No data
- Histopathology: No data
- Potential target organs: No data
- Other observations: No data

Any other information on results incl. tables

Method A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality There were no deaths.

Clinical Observations There were no signs of systemic toxicity.

Bodyweight All animals showed expected gains in bodyweight over the study period.

Necropsy No abnormalities were noted at necropsy.

Conclusion The acute oral median lethal dose (LDso) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart in Appendix I as being greater than 2500 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.