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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 December to 29 December 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at 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 402 (Acute Dermal Toxicity)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

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

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:

T-1215A

IUPAC Name:

T-1215A

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:

male/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: At the start of the study the animals weighed at least 200g. The weight variation did not exceed ± 20% of the mean weight for each sex.
- Fasting period before study: no
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2), ad libitum.
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to l8:00) and twelve hours darkness

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10
- Type of wrap if used: Selg-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The surrounding hair to the clipped area waswiped with cotton wool moistened with arachis oil BP to remove any residual test material.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): No solution made, the test substance was only moistened with arachis oil BP, prior to application.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No solution made, the test substance was only moistened with arachis oil BP, prior to application.
- Lot/batch no. (if required): No data
- Purity: No data

Duration of exposure:

24 hours

Doses:

2000 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: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing
and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity.

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

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.