N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute oral LD50 of the test substance was studied in rats.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]

EC Number:

274-157-0

EC Name:

N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]

Cas Number:

69851-61-2

Molecular formula:

C37H58N2O4

IUPAC Name:

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

Test material form:

solid

Details on test material:

- Purity: not reported

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: Ciba-Geigy
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: 160-180 g
- Fasting period before study: yes
- Housing: animals were housed in groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1°C
- Humidity (%): 55±5%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 10 hour light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE: 2% carboxymethyl cellulose

DOSAGE PREPARATION (if unusual): The test material was suspended with 2% carboxymethyl cellulose. Before treatment the suspension was homogeneously dispersed with and Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

1000, 2150, 3170, 4640, 7750, 10000 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: Physical condition and rate of deaths were monitored throught the observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No animlas died during the study.

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 9 days.

Gross pathology:

No substance related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rat): >10000 mg/kg

Executive summary:

The acute oral LD50 of the test substance was observed in male and female rats over a period of 14 days. Rats were tested at doses at 1000, 2150, 3170, 4640, 7750, and 10000 mg/kg. No deaths occurred during the study. 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 9 days. The LD50 was determined to be >10000 mg/kg.