Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Body weight was not recorded at termination.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

EC Number:

264-513-3

EC Name:

Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate

Cas Number:

63843-89-0

Molecular formula:

C42H72N2O5

IUPAC Name:

bis(1,2,2,6,6-pentamethylpiperidin-4-yl) 2-butyl-2-[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]propanedioate

Details on test material:

- Physical state: solid
- Lot/batch No.: EN 6398
no further details provided

Test animals

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from own premises
- Weight at study initiation: 160 - 180 g
- Fasting period before study: overnight
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for at least 4 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2% in water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5, 10, 20, or 50%, respectively

DOSAGE PREPARATION (if unusual): Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

464, 1000, 1470, 1670, 2150, 4640 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
- Frequency of observations and weighing: monitored throughout the whole observation period
- Necropsy of survivors performed: yes

Statistics:

LD 50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 490 mg/kg bw

Based on:

test mat.

95% CL:

1 300 - 1 708

Remarks on result:

other: Mortality found in all dose groups except the lowest . A specific target organ could not be identified from the available data.

Mortality:

see table 1: Rate of deaths

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Between the fourth and seventh day after intubation diarrhoea was also observed in animals of the four highest dosage gr

Gross pathology:

Dead and killed animals: No substance related gross organ changes were seen.

Any other information on results incl. tables

Table 1: Rate of deaths

dose [mg/kg]	Concentration % of formulation	no of animals		died within
				1 hour		24 hours		48 hours		7 days		14 days
		male	female	male	female	male	female	male	female	male	female	male	female
464	5	5	5	0	0	0	0	0	0	0	0	0	0
1000	10	5	5	0	0	0	0	0	0	0	0	1	0
1470	20	5	5	0	0	0	0	0	0	0	1	1	2
1670	20	5	5	0	0	0	0	1	1	1	3	3	5
2150	20	5	5	0	0	0	0	0	4	0	4	4	5
4640	50	5	5	0	0	0	0	1	1	4	4	5	5

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information