N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

Acute Toxicity: oral

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:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test substance, limited documentation

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

EC Number:

245-442-7

EC Name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]

Cas Number:

23128-74-7

Molecular formula:

C40H64N2O4

IUPAC Name:

N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding facility
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

DOSAGE PREPARATION (if unusual):
Test substance was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogenously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

VEHICLE
- Concentration in vehicle: 30 %

Doses:

4640, 6000, 7750 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 750 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days.

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test article in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg.

Executive summary:

The test substance was tested for acute toxicity in male and female rats in a study comparable to OECD 401 with restrictions (limited details, no body weight monitoring, no details on test substance). The test substance was dissolved in polyethylene glycol and administered by gavage to 5 rats per sex per dose (fasted overnight) in the following concentrations: 4640, 6000, 7750 mg/kg bw. No deaths occured and the LD50 was defined as greater than 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days. They were submitted at random to a necropsy at the endof the observation period. No substance related gross organ changes were reported.