Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 28, 1979 to Oct. 31, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

yes

Remarks:

(individual data were not presented; justification for choice of vehicle was not provided; light/dark cycle was 10/14 instead of 12/12, dose level too high).

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

EC Number:

253-039-2

EC Name:

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

Cas Number:

36443-68-2

Molecular formula:

C34H50O8

IUPAC Name:

ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]

Test animals

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Raised on the premises of CIBA-GEIGY Ltd. Exp. Toxicology Sisslen
- Age at study initiation: (7 to 8 weeks old)
- Weight: not reported
- Housing: housed in groups of 5 in macrolon cages type 3
- Fasting period before study: yes
- Diet and water: ad libitum rat food -NAFAG, Gossau SG ~ and water.
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg body weight

Doses:

4000, 5000, 6000, or 7000 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: body weights measured on days 1, 7 and 14; mortality measured at 1,2,3,5, and 24 hours after dosing and from day 2 to 14
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Mortality:

1 male in the 5000 group died 4 days after dosing

Clinical signs:

other: Sedation, Dyspnoea, Exophthalmos, Ruffled fur, Diarrhoea and curved body position were observed, reversible within 8 days.

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test item in rats observed over a period of 14 days is greater than 7000 mg/kg for both sexes. The test material has therefore practically no acute toxicity to the rat by this route of administration.