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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

Constituent 1
Chemical structure
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) butyl(3,5-di-tert-butyl-4-hydroxybenzyl)malonate
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:
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 groups. The surviving animals recovered within 9 to 14 days.
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

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